Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD1613 - Part A
AZD1613- Part A · 1 trial · 1 indication
Number of participants with at least one TEAE and SAE, including events leading to discontinuation or death; coded by system organ class and preferred term. Unit: participants.
Change from baseline in QT interval corrected using Fridericia's formula (QTcF) measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change from baseline in PR interval measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change from baseline in QRS duration measured on single 12-lead safety ECGs. Unit: milliseconds (ms).
Change from baseline in heart rate measured on single 12-lead safety ECGs. Unit: beats per minute (bpm).
Change from baseline in alanine aminotransferase. Unit: U/L.
Change from baseline in aspartate aminotransferase. Unit: U/L.
Change from baseline in total bilirubin. Unit: mg/dL.
Change from baseline in serum creatinine. Unit: mg/dL.
Change from baseline in eGFR calculated using CKD-EPI 2021. Unit: mL/min/1.73 m².
Change from baseline in international normalized ratio- (INR). Unit: unitless.
Change from baseline in prothrombin time. Unit: seconds (s).
Change from baseline in aPTT. Unit: seconds (s).
Change from baseline in UACR (geometric mean of triplicates at each visit). Unit: mg/g.
Change from baseline in supine systolic blood pressure. Unit: mmHg.
Change from baseline in supine diastolic blood pressure. Unit: mmHg.
Change from baseline in supine heart rate. Unit: bpm.
Change from baseline in oral body temperature. Unit: °C.
Change from baseline in respiratory rate. Unit: breaths per minute.
Change from baseline in pulse oximetry oxygen saturation. Unit: percent (%).
| Arm | Type | Description |
|---|---|---|
| Part A - Cohort A1 | EXPERIMENTAL | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Part A - Cohort A2 | EXPERIMENTAL | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Part B - Chinese Cohort | EXPERIMENTAL | Participants will receive 4 doses of AZD1613 or placebo on days 1, 29, 57 and 85. |
| Name | Type | Description |
|---|---|---|
| AZD1613 - Part A | DRUG | Part A - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. |
| Placebo - Part A | DRUG | Part A - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT. |
| AZD1613 - Part B | DRUG | Part B - Participants will be administered doses of AZD1613 on days 1, 29, 57, and 85 according to randomization in IRT. |
| Placebo - Part B | DRUG | Part B - Participants will be administered doses of placebo on days 1, 29, 57, and 85 according to randomization in IRT. |
Inclusion Criteria: * Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed centrally. Genetic testing results will not be used for eligibility purposes * eGFR = 45 to 90 mL/min /1.73m2 * Body weight ≥ 45 kg and body mass index within the range 18 to 35 kg/m2 (inclusive)....
AZD1613 is an investigational small molecule being developed for Autosomal Dominant Polycystic Kidney Disease (ADPKD). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in adults with ADPKD to evaluate its safety, tolerability, and pharmacokinetics.
The specific molecular target of AZD1613 has not been disclosed in available information. The drug is a small molecule being investigated for the treatment of Autosomal Dominant Polycystic Kidney Disease, but its mechanism of action has not been publicly detailed.
AZD1613 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Autosomal Dominant Polycystic Kidney Disease.
AZD1613 is currently in Phase 1 clinical development. It is an investigational drug and has not received approval from regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants to assess the safety, tolerability, and pharmacokinetics of the drug in adults with Autosomal Dominant Polycystic Kidney Disease.
AZD1613 is being studied in a Phase 1 clinical trial registered as NCT07228364, titled 'Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease.' The trial is recruiting 40 participants across the United States, China, and the United Kingdom, and is a randomized, double-blind, controlled study.
Yes, AZD1613 and AZD1613 - Part A refer to the same drug candidate. The name 'AZD1613 - Part A' is used to designate a specific part of the clinical development program for AZD1613, which is being investigated for the treatment of Autosomal Dominant Polycystic Kidney Disease.