Study identifier:D7930C00004
ClinicalTrials.gov identifier:NCT06812780
EudraCT identifier:N/A
CTIS identifier:N/A
A Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD2389 (CAMPOLINA)
Hepatic Impairment
Phase 1
Yes
AZD2389
All
36
Interventional
18 Years - 85 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Feb 2025 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Participants with normal hepatic function (sex-, age-, and body mass index [BMI]-matched) | Drug: AZD2389 Single oral dose of AZD2389 in participants from all cohorts |
Experimental: Cohort 2 Participants with mild hepatic impairment (CP A classification) | Drug: AZD2389 Single oral dose of AZD2389 in participants from all cohorts |
Experimental: Cohort 3 Participants with moderate hepatic impairment (CP B classification) | Drug: AZD2389 Single oral dose of AZD2389 in participants from all cohorts |
Experimental: Cohort 4 Participants with severe hepatic impairment (CP C classification) | Drug: AZD2389 Single oral dose of AZD2389 in participants from all cohorts |