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Also known as [14C]AZD5462 Oral Solution, AZD5462 film-coated tablet, [14C]AZD5462 Solution for Infusion
AZD5462 · 2 trials · 2 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.
| 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). |
| 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. |
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 developed for chronic heart failure and renal impairment. AstraZeneca has studied it in a Phase 2b trial in patients with chronic heart failure and a Phase 1 pharmacokinetic study in participants with renal impairment. It is not approved for any indication and remains in clinical development.
AZD5462 is being developed by AstraZeneca PLC, which trades on Nasdaq under the ticker AZN. The company sponsored both the Phase 2b chronic heart failure study and the Phase 1 renal impairment pharmacokinetic study of the compound.
AZD5462 has completed a Phase 2b trial in chronic heart failure and a Phase 1 pharmacokinetic study in renal impairment. No active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
AZD5462 has been evaluated in two completed trials. NCT06299826 was a Phase 2b study in 375 patients with chronic heart failure across the United States, Europe, Japan and India. NCT06661733 was a Phase 1 pharmacokinetic, safety and tolerability study in 16 participants with renal impairment in Bulgaria.
Yes, [14C]AZD5462 Oral Solution is an alternative name for AZD5462. The carbon-14 labeled oral solution formulation is used in clinical studies of the same investigational compound, so searches for either name refer to the same AstraZeneca drug candidate.