NCT06661733

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.

Detailed description

This is a Phase I, single dose, non-randomised, open-label, parallel group study to assess the PK, safety, and tolerability of AZD5462 in male and female participants (females of non-childbearing potential) with renal impairment. This study consists of 3 cohorts: 1. Cohort 1: Participants with severe renal impairment (eGFR ≥ 15 to \< 30mL/min/1.73 m2, not requiring dialysis). 2. Cohort 2: Participants who are healthy control (eGFR ≥ 90 mL/min/1.73 m2) matched at a group level to Cohort 1. 3. Cohort 3 (conditional): Participants with moderate renal impairment (eGFR ≥ 30 to \< 60mL/min/1.73 m2). This study comprises of three periods: * Screening period: 21 days * In-patient (Treatment) period: 4 days * Out-patient visit: On Day 4, participants will return to the study site to undergo safety assessments and provide blood samples 72 hours post-dose. Participants may stay at the study site for this visit if preferred. * Follow-up visit: On Day 7 (± 2), participants will return to the study site for safety assessments. The duration of the study for an individual participant from the Screening Visit to the Follow-up Visit will be approximately 4 weeks.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	AZD5462	Participants will receive AZD5462 orally.

Timeline

• Start date: 2024-11-18
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2024-10-28
• Last updated: 2025-12-03

Locations

1 site across 1 country: Bulgaria

Regulatory

• FDA-regulated drug study