NCT06693765

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants

A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A study to investigate the pharmacokinetics, safety, and tolerability of AZD4144 in participants with severe renal impairment, end-stage kidney disease, and in healthy participants.

Detailed description

This is an open-label, single dose, non-randomised, parallel group, Phase I study to assess the pharmacokinetics, safety, and tolerability of AZD4144 in male and female participants with severe renal impairment and end-stage kidney disease (ESKD) compared with healthy control participants. The study will comprise of: * A Screening Period of 21 days. * Cohort 1, 2, 4, and 5: a single Treatment Period with an in-clinic period of 7 days. * Cohort 3: two Treatment Periods each with an in-clinic period of 7 days, and a washout period of 6 days after the in-clinic treatment period. * A Follow-up visit 7 days following discharge.

Conditions

• Renal Impairment
• End-stage Kidney Disease
• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD4144	AZD4144 will be administered orally.

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2024-11-18
• Last updated: 2026-04-07

Locations

2 sites across 2 countries: Bulgaria, Romania