Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9977 · 9 trials · 11 indications
The effect of AZD9977 in combination with dapagliflozin compared with dapagliflozin alone on UACR assessed. Urine samples were collected for the analysis of UACR. UACR (milligrams per gram \[mg/g\]) was calculated as 10 x urine albumin (mg per deciliter \[mg/dL\])/urine creatinine (g/dL). Change from baseline in UACR at the end of 12 weeks of study treatment was calculated as the average of the UACR values at Week 12 and was analyzed by a mixed-effects model for repeated measures (MMRM). Due to early removal of arms (AZD9977 150 mg monotherapy and Placebo), the study objectives were revised and the MMRM analysis included the 4 remaining arms (AZD9977 15 mg + Dapagliflozin, AZD9977 50 mg + Dapagliflozin, AZD9977 150 mg + Dapagliflozin, and Dapagliflozin 10 mg). Since 2 arms were removed from the study resulting in fewer participants only descriptive statistics are shown for those two arms without formal comparison.
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
Assessment of the total radioactivity by measuring the cumulative amount of AZD9977 excreted (CumAe)
Assessment of the rates and routes of elimination by measuring the cumulative amount excreted and expressed as a percentage of the administered dose (CumFe)
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To assess the PK of AZD9977 following administration of AZD9977
To access pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole
To access pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole
To access pharmacokinetics (PK) of AZD9977 in healthy volunteers when administered alone and in combination with multiple doses of itraconazole
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. Serious AEs will be recorded from the time of screening.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. Blood pressure includes both systolic and diastolic BP.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. The complete physical examinations will include an assessment of the general appearance, skin, cardiovascular, respiratory, abdomen, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. Electrolyte Measurements includes Bicarbonate, Calcium, Chloride, Potassium, Sodium
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants.
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. Microscopy should be done (if positive for protein or blood): red blood cells (RBC), white blood cells (WBC), Casts (Cellular, Granular, Hyaline)
To investigate the safety and tolerability of AZD9977 following oral administration of single and multiple ascending doses at steady state in healthy Japanese participants. Urinary Electrolytes: Calcium, Potassium, Chloride, Sodium, Creatinine and Uric acid.
To assess Frel by assessments of PK parameters AUC after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
To assess Frel by assessments of PK parameters AUClast after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
To assess Frel by assessments of PK parameters AUC\[0-24\] after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
To assess Frel by assessments of PK parameters Cmax after administration of single oral dose of AZD9977 capsule and ER (fast rate and Int. rate) capsules by comparison with AZD9977 oral suspension (reference).
To assess AUC after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
To assess AUClast after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
To assess Cmax after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
To assess AUC(0-24) after administration of single oral dose of AZD9977 capsule, ER capsules (fast rate and Int. rate) and oral suspension (reference).
To evaluate the influence of food by comparing AUC and Cmax under fasting and fed conditions for one of the solid formulations evaluated in Part A.
To assess AEs as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. AEs will be collected from the start of screening throughout the treatment period up to and including the follow-up visit. Serious AEs will be recorded from the time of informed consent.
To measure SBP as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. SBP will be collected after the subject has rested in the supine position for at least 10 minutes.
To measure DBP as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. DBP will be collected after the subject has rested in the supine position for at least 10 minutes.
To measure pulse as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. Pulse rate will be collected after the subject has rested in the supine position for at least 10 minutes.
To assess the urine volume as variable of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess any clinically significant abnormalities on cardiac electrophysiological parameters as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. 12-lead safety ECG and dECG will be obtained after the participant rested in the supine position for at least 10 minutes. Safety ECG will be collected at the end of each dECG recording. Various dECG variables like time between 2 consecutive R waves on ECG (RR), ECG interval measured form onset of P wave to the onset of QRS complex (PR), ECG interval measured from onset of QRS complex to the J point (QRS) and ECG interval measured form onset of QRS complex to the end of the T wave (QT intervals) will be reported. Derived parameters like QT interval corrected for heart rate using Fridericia's formula (QTcF), heart rate (HR) and others, as applicable are also calculated.
To assess any clinically significant abnormalities in the cardiovascular system functioning as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. A 2-lead real-time telemetry ECG will be used to assess the heart rate.
To assess the differential white blood cell count (absolute count of basophils, eosinophils, lymphocytes, monocyets and neutrophils) as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the HCT (red blood cells \[RBC\]) and reticulocyte absolute count (immature RBCs) as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the Hb as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the MCH as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the MCHC as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the MCV as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess platelets count as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess RBC and white blood cells (WBC) count as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum albumin level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum CRP level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum CK level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum creatinine level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum fasting glucose level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum calcium, potassium, phosphate and sodium level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum urea and uric acid level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST) and Gamma glutamyl transpeptidase (GGT) level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum bilirubin (total and unconjugated) level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum cholesterol and triglycerides level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum LF level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum SHBG level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum testosterone level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum aldosterone level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum HbA1c level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum high-sensitivity troponin T level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum NT-proBNP level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the serum FSH level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the urine protein level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
To assess the urine blood level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension. If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, WBC, casts \[cellular, granular, hyaline\]).
To assess the urine glucose level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the urine uric acid level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the urine creatinine level as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
To assess the urine electrolytes level (calcium, chloride, potassium and sodium) as variables of safety and tolerability after administration of multiple dose of AZD9977 oral suspension.
The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose. NOTE: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours.
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
To assess the safety and tolerability of single ascending doses of AZD9977
| Arm | Type | Description |
|---|---|---|
| AZD9977 Dose A + dapagliflozin 10 mg | EXPERIMENTAL | Participants will receive once daily oral dose A of AZD9977 and 10 mg dapagliflozin for 12 weeks. |
| AZD9977 Dose B + dapagliflozin 10 mg | EXPERIMENTAL | Participants will receive once daily oral dose B of AZD9977 and 10 mg dapagliflozin for 12 weeks. |
| AZD9977 Dose C + dapagliflozin 10 mg | EXPERIMENTAL | Participants will receive once daily oral dose C of AZD9977 and 10 mg dapagliflozin for 12 weeks. |
| Dapagliflozin 10 mg | EXPERIMENTAL | Participants will receive once daily oral dose of dapagliflozin 10 mg alone for 12 weeks. |
| AZD9977 | EXPERIMENTAL | In Period 1, one 100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capsules) and one 100 µg dose of \[14C\]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL). In Period 2, one 100 mg dose of \[14C\]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq). |
| Treatment - AZD9977 | EXPERIMENTAL | There are 4 cohorts in this arm based on renal function (mild, moderate, severe, and normal). Each cohort will have 8 participants. |
| Single AZD9977 | EXPERIMENTAL | During this treatment period, healthy participants will be administered with a single AZD9977 (Dose 1) dose, in the fed state, on Day 1 followed by at least 3 days washout period. |
| Itraconazole + AZD9977 | EXPERIMENTAL | During this treatment period, healthy participants will be administered with Itraconazole (Dose 2) from Day 4 to Day 8 plus will be administrated with AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole will be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
| Placebo | PLACEBO_COMPARATOR | Each participant will receive placebo at the selected dose level on Day 1 and from Day 3 to 9, with single dose on Day 1 and Day 9 and twice a day (BID) dosing on Day 3 to Day 8. No dose will be given on Day 2. |
| Treatment sequence 1 | EXPERIMENTAL | In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 oral suspension (reference) AZD9977 capsule AZD9977 ER capsule (fast rate) AZD9977 ER capsule (Int. rate) |
| Treatment sequence 2 | EXPERIMENTAL | In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 capsule AZD9977 ER capsule (fast rate) AZD9977 ER capsule (Int. rate) AZD9977 oral suspension (reference) |
| Treatment sequence 3 | EXPERIMENTAL | In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 ER capsule (fast rate) AZD9977 ER capsule (Int. rate) AZD9977 Oral suspension (reference) AZD9977 capsule |
| Treatment sequence 4 | EXPERIMENTAL | In Part A, randomized subjects will receive orally single dose of all treatments in fasted condition in the following sequence: AZD9977 ER capsule (Int. rate) AZD9977 Oral suspension (reference) AZD9977 capsule AZD9977 ER capsule (fast rate) |
| Cohort 1 | EXPERIMENTAL | Randomized subjects will receive AZD9977 50 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose Day 2 to Day 7 |
| Cohort 2 | EXPERIMENTAL | Randomized subjects will receive AZD9977 150 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose on Day 2 to Day 7 |
| Cohort 3 | EXPERIMENTAL | Randomized subjects will receive AZD9977 300 mg or placebo oral suspension single dose on Day 1 and Day 8; twice daily dose on Day 2 to Day 7 |
| Treatment Sequence 5 | EXPERIMENTAL | Period 1: fludrocortisone + eplerenone + AZD9977 Period 2: fludrocortisone + eplerenone + AZD9977 Placebo Period 3: fludrocortisone + AZD9977 Placebo Period 4: fludrocortisone + AZD9977 Period 5: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment Period 6: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment |
| Treatment Sequence 6 | EXPERIMENTAL | Period 1: fludrocortisone + AZD9977 Placebo Period 2: fludrocortisone + eplerenone + AZD9977 Period 3: fludrocortisone + AZD9977 Period 4: fludrocortisone + eplerenone + AZD9977 Placebo Period 5: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment Period 6: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment |
| Treatment Sequence 7 | EXPERIMENTAL | Period 1: fludrocortisone + AZD9977 Period 2: fludrocortisone + AZD9977 Placebo Period 3: fludrocortisone + eplerenone + AZD9977 Placebo Period 4: fludrocortisone + eplerenone + AZD9977 Period 5: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment Period 6: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment |
| Treatment Sequence 8 | EXPERIMENTAL | Period 1: fludrocortisone + eplerenone + AZD9977 Placebo Period 2: fludrocortisone + AZD9977 Period 3: fludrocortisone + eplerenone + AZD9977 Period 4: fludrocortisone + AZD9977 Placebo Period 5: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment Period 6: fludrocortisone + eplerenone and/or AZD9977 or AZD9977 Placebo treatment |
| AZD9977 oral suspension, single doses | EXPERIMENTAL | In Part A up to 10 cohorts with single ascending doses with AZD9977 as oral suspension. In Part B AZD9977 as oral suspension in IntelliCap® capsule |
| Placebo, oral suspension, single doses | PLACEBO_COMPARATOR | In Part A up to 10 cohorts with single doses with matching placebo to AZD9977 |
| AZD9977, oral solution, single dose | EXPERIMENTAL | In Part B, of oral solution of AZD9977 will be used as reference |
| Name | Type | Description |
|---|---|---|
| AZD9977 | DRUG | Participants will receive AZD9977 as per the arms they are randomized. |
| Dapagliflozin | DRUG | Participants will receive dapagliflozin as per the arms they are randomized. |
| AZD9977 capsule 50 mg | DRUG | 100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capusles) |
| [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL) | DRUG | One 100 µg dose of \[14C\]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL) |
| [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq) | DRUG | One 100 mg dose of \[14C\]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq) |
| Itraconazole | DRUG | Participants will receive Itraconazole daily (Dose 2) capsule orally once daily from Day 4 to Day 8 plus will be administered AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole has to be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977. |
| Placebo | DRUG | Randomized participants will receive oral dose of matching placebo. |
| AZD9977 Oral suspension (reference) | DRUG | Randomized subjects will receive single oral dose of AZD9977 oral suspension 15 mg/mL on Days 1, 3, 5 and 7 in Part A. |
| AZD9977 capsule | DRUG | Randomized subjects will receive single oral dose of AZD9977 capsule 65 mg on Days 1, 3, 5 and 7 in Part A. |
| AZD9977 ER capsule (fastvrate) | DRUG | Randomized subjects will receive single oral dose of AZD9977 ER capsule (fast rate) 65 mg on Days 1, 3, 5 and 7 in Part A. |
| AZD9977 ER capsule (Int. rate) | DRUG | Randomized subjects will receive single oral dose of AZD9977 ER capsule (Int rate) 65 mg on Days 1, 3, 5 and 7 in Part A. |
| AZD9977 oral suspension | DRUG | AZD9977 oral suspension, single dose |
| AZD9977 placebo oral suspension | DRUG | oral suspension, single dose |
| Fludrocortisone, tablets | DRUG | Loading dose of 0.5 mg and maintenance doses of 0.1 mg every second hour up to a total dose of 1.0 mg per treatment period (may be modified to up to 1.3 mg based on emerging data) |
| Eplerenone, tablets | DRUG | 100 mg (2 x 50 mg tablets) single dose, may be modified based on emerging data (will not exceed 500 mg per treatment period) |
| AZD9977, oral suspension | DRUG | Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B) |
| Placebo, oral suspension | DRUG | Matching placebo |
| AZD9977, oral solution | DRUG | AZD9977, single dose of oral solution in Part B as reference |
Inclusion Criteria: Participants are included in the study if any of the following criteria apply: * Documented diagnosis of stable symptomatic HF (New York Heart Association class II-III) at screening, and a medical history of typical symptoms and signs of HF in those who are currently receiving ...
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AZD9977 is an investigational small molecule being developed by AstraZeneca for cardiovascular conditions, including heart failure and heart failure with preserved ejection fraction (HFpEF). It has been studied in healthy volunteers for safety, tolerability, and pharmacodynamics, and in participants with renal impairment. It is not approved and remains in Phase 1 clinical development.
AZD9977 is a small molecule in development for heart failure. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on safety, tolerability, pharmacokinetics, and pharmacodynamics in early-stage trials.
AZD9977 is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers and in patients with renal impairment.
AZD9977 is in Phase 1 clinical development. All completed trials for AZD9977 are Phase 1 studies, including single and multiple ascending dose studies in healthy participants and a study in participants with renal impairment. The drug is investigational and has not been approved by regulatory authorities.
AZD9977 has been studied in several completed Phase 1 trials, including NCT02484729, a single ascending dose study in healthy males; NCT03801967, a Japanese healthy participant study; NCT04469907, a renal impairment study; and NCT04686591, an absolute bioavailability and ADME study. These trials assessed safety, tolerability, and pharmacokinetics.
AZD9977 is the code name used for this investigational compound in clinical trials. No alternative brand names or other designations have been reported in the available clinical trial information. The drug is identified solely as AZD9977 in the studies conducted by AstraZeneca.