Study identifier:D7260C00006
ClinicalTrials.gov identifier:NCT06742762
EudraCT identifier:N/A
CTIS identifier:N/A
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
Renal Impairment
Phase 1
Yes
AZD5004
All
21
Interventional
18 Years - 80 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group 1 Participants with severe renal impairment will receive a single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |
Experimental: Group 2 Participants with normal renal function will receive a single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |
Experimental: Group 3 (Optional) Participants with moderate renal impairment will receive a single oral dose of AZD5004 under fasted conditions. | Drug: AZD5004 Dose 1 Other Name: ECC5004 Other Name: Dose 1 |