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A Phase I, Multicentre, Single-Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic 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 mild, moderate, and severe hepatic impairment compared with participants with normal hepatic 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 mild, moderate, or severe hepatic impairment compared with participants with normal hepatic function. Participants will be enrolled within the following groups based on their Child Pugh classification score as determined at screening: Group 1: Participants with mild hepatic impairment (Child Pugh Class A, score of 5 or 6). Group 2: Participants with moderate hepatic impairment (Child Pugh Class B, score of 7 to 9). Group 3: Participants with severe hepatic impairment (Child Pugh Class C, score of 10 to 15). Group 4: Participants with normal hepatic function matched on a group level regarding sex, age, and body weight to the impaired participants.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Lake Forest, California, United States
Research Site
Rialto, California, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
San Antonio, Texas, United States
Start Date
December 19, 2024
Primary Completion Date
October 2, 2025
Completion Date
October 2, 2025
Last Updated
October 15, 2025
33
ACTUAL participants
AZD5004
DRUG
Lead Sponsor
AstraZeneca
Collaborators
NCT07324616
NCT04271488
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 ConditionsNCT06952634