NCT04949438

A Study to Assess the Pharmacokinetics (Uptake of Drugs by the Body), Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers

A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD4831 in Participants With Severe Renal Impairment and Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a study to compare AZD4831 pharmacokinetic (PK) parameters between participants with severe renal impairment and matched healthy volunteers following a single dose administration.

Detailed description

All participants will receive a single oral dose of AZD4831 under fasted conditions and will be involved in the study approximately 2 weeks after dosing and up to approximately 38 days from screening. Approximately 10 participants will be enrolled into each of the 2 cohorts parallelly and receive the study intervention to achieve 8 evaluable participants in each cohort. * Cohort 1: 10 participants with severe renal impairment (Estimated glomerular filtration rate \[eGFR\] of ≥15 to \<30 mL/min/1.73m\^2) * Cohort 2: 10 matched healthy volunteers with normal renal function (eGFR of ≥90 mL/min/1.73m\^2). The study will comprise of the following study periods: * Screening period (21 days): participants will be screened for eligibility. * Treatment period (3 days): participants will be admitted to the study centre in the evening of (Day -1) the day before administration of a single oral dose of AZD4831 (Day 1), and will be discharged after at least 24 h post-dose (Day 2). * Follow-up period (13±2 days): participants will attend 5 visits at the study centre for PK sampling and safety assessments on Days 3, 5, 8, 11 and 15.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	AZD4831	Participants will receive a single dose of AZD4831 administered with 240 mL of water after an overnight fast of at least 10 hours.

Timeline

• Start date: 2022-01-21
• Primary completion: 2022-03-04
• Completion: 2022-03-04
• First posted: 2021-07-02
• Last updated: 2022-04-05

Locations

1 site across 1 country: Bulgaria

Regulatory

• FDA-regulated drug study