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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
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.
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).
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Miami Lakes, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Orlando, Florida, United States
Start Date
December 17, 2024
Primary Completion Date
April 20, 2025
Completion Date
April 20, 2025
Last Updated
June 8, 2025
16
ACTUAL participants
AZD5004
DRUG
Lead Sponsor
AstraZeneca
NCT07154901
NCT07165015
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06352411