NCT06742762

A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

• 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

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function.

Detailed description

This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD5004 in male and female participants with severe renal impairment and moderate renal impairment (optional) compared with male and female participants with normal renal function. Participants will be assigned to the following groups based on eGFR determined at screening by a local laboratory using serum creatinine: Group 1: Participants with severe renal impairment (eGFR \< 30 mL/min), not on dialysis. Group 2: Participants with normal renal function (eGFR of ≥ 90 mL/min) matched by sex, age, and body weight on a group level to the impaired participants. Group 3 (optional): Participants with moderate renal impairment (eGFR ≥ 30 to \< 60 mL/min).

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	AZD5004	Dose 1

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-04-20
• Completion: 2025-04-20
• First posted: 2024-12-19
• Last updated: 2025-06-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study