Approval Probability
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Adjusted LOA
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AZD5462 · 5 trials · 3 indications
To evaluate the effect of AZD5462 after treatment in participants with HF.
The AUCinf of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The AUClast of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The tmax of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The Cmax of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The λz of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The t½λz of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The CL/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The CLNR/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The Vz/F of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The CLR of a single oral dose of AZD5462 in participants with renal impairment compared with healthy control participants matched at a group level will be assessed.
The AUCinf of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
The AUClast of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
The Cmax of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
The effect of AZD5462 on the AUCinf of oral midazolam, rosuvastatin, and digoxin will be assessed.
The effect of AZD5462 on the AUClast of oral midazolam, rosuvastatin, and digoxin will be assessed.
The effect of AZD5462 on the Cmax of oral midazolam, rosuvastatin, and digoxin will be assessed.
Assessment of the safety and tolerability of AZD5462 following administration of single ascending doses (Part A) and multiple ascending doses (Part B).
| Arm | Type | Description |
|---|---|---|
| Cohort A & B: AZD5462 low dose | EXPERIMENTAL | Participants will receive low dose of AZD5462 as OD tablets for 24 weeks. |
| Cohort A & B: AZD5462 medium dose | EXPERIMENTAL | Participants will receive medium dose of AZD5462 as OD tablets for 24 weeks. |
| Cohort A & B: AZD5462 high dose | EXPERIMENTAL | Participants will receive high dose of AZD5462 as OD tablets for 24 weeks. |
| Cohort A & B: Placebo | EXPERIMENTAL | Participants will receive matching placebo OD tablets for 24 weeks. |
| Cohort 1 | EXPERIMENTAL | Participants with severe renal impairment (eGFR ≥ 15 to \< 30 mL/min/1.73 m2, not requiring dialysis). |
| Cohort 2 | EXPERIMENTAL | Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1. |
| Cohort 3 (conditional) | EXPERIMENTAL | Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min/1.73 m2). |
| Treatment A | EXPERIMENTAL | Participants will receive Dose A orally as a film-coated tablet. |
| Treatment B | EXPERIMENTAL | Participants will receive Dose A orally as a film-coated tablet. |
| Treatment C | EXPERIMENTAL | Participants will receive Dose B orally as a film-coated tablet. |
| Treatment D | EXPERIMENTAL | Participants will receive Dose B orally as an oral solution. |
| Treatment E | EXPERIMENTAL | Participants will receive Dose C orally as a film-coated tablet. |
| Treatment F | EXPERIMENTAL | Participants will receive Dose C orally as a film-coated tablet. |
| Treatment Arm A: High dose | EXPERIMENTAL | Participants will receive the Investigational Medicinal Product (IMP), AZD5462 Dose A starting on Day 6 and continued until Day 18 and the following approved medicinal products: * Midazolam * Rosuvastatin * Digoxin |
| Treatment Arm B: Low dose | EXPERIMENTAL | Participants will receive the IMP, AZD5462 Dose B starting on Day 6 and continued until Day 18 and the following approved medicinal products: * Midazolam * Rosuvastatin * Digoxin |
| Cohort A1: AZD5462 Dose 1 | EXPERIMENTAL | Randomized healthy participants will receive Dose 1 of AZD5462. |
| Cohort A2: AZD5462 Dose 2 | EXPERIMENTAL | Randomized healthy participants will receive Dose 2 of AZD5462. |
| Cohort A3: AZD5462 Dose 3 | EXPERIMENTAL | Randomized healthy participants will receive Dose 3 of AZD5462. |
| Cohort A4 Japanese descent: AZD5462 Dose 3 | EXPERIMENTAL | Randomized participants of Japanese descent will receive Dose 3 of AZD5462. |
| Cohort A5: AZD5462 Dose 4 | EXPERIMENTAL | Randomized healthy participants will receive Dose 4 of AZD5462. |
| Cohort A6 Japanese descent: AZD5462 Dose 4 | EXPERIMENTAL | Randomized participants of Japanese descent will receive Dose 4 of AZD5462. |
| Cohort A7: AZD5462 Dose 5 | EXPERIMENTAL | Randomized healthy participants will receive Dose 5 of AZD5462. |
| Cohort A8 Japanese descent: AZD5462 Dose 5 | EXPERIMENTAL | Randomized participants of Japanese descent will receive Dose 5 of AZD5462. |
| Part A: Placebo (Healthy Participants) | PLACEBO_COMPARATOR | Randomized healthy participants will receive Placebo matched to AZD5462. |
| Part A: Placebo (Japanese descent participants) | PLACEBO_COMPARATOR | Randomized participants of Japanese descent will receive Placebo matched to AZD5462. |
| Cohort B1: AZD5462 Dose 1 | EXPERIMENTAL | Randomized healthy participants will receive Dose 1 of AZD5462. |
| Cohort B2: AZD5462 Dose 2 | EXPERIMENTAL | Randomized healthy participants will receive Dose 2 of AZD5462. |
| Cohort B3: AZD5462 Dose 3 | EXPERIMENTAL | Randomized healthy participants will receive Dose 3 of AZD5462. |
| Cohort B4: AZD5462 Dose 4 | EXPERIMENTAL | Randomized healthy participants will receive Dose 4 of AZD5462. |
| Cohort B5 Japanese descent: AZD5462 Dose 4 | EXPERIMENTAL | Randomized participants of Japanese descent will receive Dose 4 of AZD5462. |
| Part B: Placebo (Healthy participants) | PLACEBO_COMPARATOR | Randomized healthy participants will receive Placebo matched to AZD5462. |
| Part B: Placebo (Japanese descent participants) | PLACEBO_COMPARATOR | Randomized participants of Japanese descent will receive Placebo matched to AZD5462. |
| Name | Type | Description |
|---|---|---|
| AZD5462 | DRUG | Participants will receive low, medium \& high doses of film-coated tablets of AZD5462 OD orally. |
| Placebo | DRUG | Participants will receive matching doses of film-coated tablets of Placebo OD orally. |
| Midazolam | DRUG | Participants will receive a single dose of midazolam in the morning of Day 1 and in the morning of Day 15 in both the arms. |
| Rosuvastatin | DRUG | Participants will receive rosuvastatin as a single dose administered with digoxin at the same time in the morning of Day 2, Day 6, and in the morning of Day 16 in both the arms. |
| Digoxin | DRUG | Participants will receive digoxin as a single dose administered with rosuvastatin at the same time in the morning of Day 2, Day 6, and in the morning of Day 16 in both the arms. |
Inclusion Criteria: * Participants must have a pre-existing diagnosis of HF NYHA FC II to IV. * Participants must be on stable HF standard of care medication for at least 4 weeks prior to consent and during the Screening period. * Minimum body mass index (BMI) of 18 kilograms per meter square (kg/m...
AZD5462 is an investigational small molecule being studied for chronic heart failure. It has completed a Phase IIb trial in patients with chronic heart failure. The drug is also being evaluated in healthy participants and in people with renal impairment for pharmacokinetic studies. AZD5462 is not approved and remains in clinical development.
AZD5462 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials of AZD5462 in the cardiovascular therapeutic area, including studies in chronic heart failure and renal impairment.
AZD5462 is in Phase 2 clinical development. A Phase IIb study of AZD5462 in patients with chronic heart failure has been completed. Earlier Phase 1 studies in healthy participants and in participants with renal impairment have also been completed. The drug is investigational and not yet approved.
AZD5462 has completed four clinical trials. NCT06299826 is a Phase IIb study in chronic heart failure with 375 participants. NCT05395117 and NCT05512806 are Phase 1 studies in healthy participants. NCT06661733 is a Phase 1 study in participants with renal impairment. All trials are completed.
AZD5462 is the drug name used in clinical trials. No alternative names for AZD5462 have been reported. The drug is a small molecule being developed by AstraZeneca for cardiovascular conditions, including chronic heart failure.
AZD5462 is a small molecule being studied for chronic heart failure. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is in Phase 2 development by AstraZeneca for cardiovascular indications.