Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4144 · 8 trials · 9 indications
The total area under the curve for 24-hour creatinine clearance measured throughout the treatment period.
area under the concentration-time curve from zero to infinity
area under the concentration-time curve from zero to the last measurable concentration
area under the curve from time zero to time 144hours post dose
maximum observed plasma concentration
To assess the effect of itraconazole on the PK (AUCinf) of AZD4144
To assess the effect of itraconazole on the PK (AUClast) of AZD4144
To assess the effect of itraconazole on the PK (Cmax) of AZD4144
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
The safety and tolerability of AZD4144 compared with placebo will be assessed.
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.
The AUCinf of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
The AUClast of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
The Cmax of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.
The safety and the tolerability of AZD4144 compared with placebo will be evaluated.
The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.
To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls.
| Arm | Type | Description |
|---|---|---|
| Arm 1 (AZD4144) | EXPERIMENTAL | AZD4144 solution for IV infusion |
| Arm 2 (Placebo) | PLACEBO_COMPARATOR | Placebo concentrate for solution for infusion |
| Group 1 | EXPERIMENTAL | Participants with mild hepatic impairment (CP Class A, score of 5 or 6) |
| Group 2 | EXPERIMENTAL | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). |
| Group 3 | EXPERIMENTAL | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). |
| Group 4 | EXPERIMENTAL | Participants with normal hepatic function matched on a group level regarding sex, age, and BMI to the impaired groups |
| Arm 1: Oral AZD4144 | EXPERIMENTAL | In Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15. |
| Arm 2: IV Infusion AZD4144 | EXPERIMENTAL | In Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15. |
| Arm 1: AZD4144 | EXPERIMENTAL | Participants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions. |
| Arm 2: AZD4144 + Omeprazole | EXPERIMENTAL | Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F). |
| AZD4144 | EXPERIMENTAL | Participants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days. |
| Treatment sequence AB | EXPERIMENTAL | Participants will receive single dose of rosuvastatin under fasted condition (Treatment A), followed by a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B). |
| Treatment sequence BA | EXPERIMENTAL | Participants will receive a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B), followed by a single dose of rosuvastatin under fasted condition (Treatment A). |
| Cohort 1: AZD4144 | EXPERIMENTAL | Participants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 2: AZD4144 | EXPERIMENTAL | Healthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 3: AZD4144 | EXPERIMENTAL | Participants with ESKD on intermittent haemodialysis will receive a single oral dose of AZD4144 on the first day of Treatment Period 1 and Treatment Period 2. |
| Cohort 4: AZD4144 | EXPERIMENTAL | Participants with moderate renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Cohort 5: AZD4144 | EXPERIMENTAL | Participants with mild renal impairment will receive a single oral dose of AZD4144 on Day 1. |
| Name | Type | Description |
|---|---|---|
| AZD4144 | DRUG | Intravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned. |
| Placebo | DRUG | Intravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned. |
| Itraconazole | DRUG | Itraconazole will be administered orally. |
| Omeprazole | DRUG | Participants will receive omeprazole orally. |
| Rosuvastatin | DRUG | Oral tablet of rosuvastatin will be administered. |
Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |
AZD4144 is an investigational small molecule being developed by AstraZeneca for cardiovascular conditions. It is being studied in participants with chronic kidney disease, atherosclerotic cardiovascular disease, hepatic impairment, and sepsis, as well as in healthy participants for pharmacokinetic studies. It is currently in Phase 1 clinical development.
AZD4144 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol AZN. AstraZeneca is conducting multiple Phase 1 clinical trials to evaluate the safety, tolerability, and pharmacokinetics of AZD4144 in various patient populations.
AZD4144 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. AstraZeneca is currently conducting Phase 1 trials to assess its safety, tolerability, and pharmacokinetics in healthy participants and in patients with conditions such as chronic kidney disease and hepatic impairment.
AZD4144 has been studied in several Phase 1 trials. NCT06675175 assessed its safety and pharmacodynamics in participants with atherosclerotic cardiovascular disease and chronic kidney disease. NCT06925854 investigated its effect on rosuvastatin pharmacokinetics in healthy participants. NCT07685600 is recruiting to study the effect of itraconazole on AZD4144 pharmacokinetics, and NCT07783308 will investigate hepatic impairment effects.
AZD4144 is the primary identifier for this investigational compound. No alternative names or brand names have been disclosed in the clinical trial information. It is being developed solely by AstraZeneca and is identified by this code name in all registered clinical studies.