Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and its Metabolite
Study identifier:ACE-HI-102
ClinicalTrials.gov identifier:NCT03968848
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Open-Label, Single-Dose Study to Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and its Metabolite (ACP-5862)
Medical condition
Hepatic Impairment, Hepatic insufficiency, Healthy subjects
Phase
Phase 1
Healthy volunteers
Yes
Study drug
acalabrutinib
Sex
All
Actual Enrollment
16
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 12 Nov 2018
Primary Completion Date: 13 Mar 2019
Study Completion Date: 29 Mar 2019
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2021 by Acerta Pharma BV
Sponsors
Acerta Pharma BV
Collaborators
AstraZeneca
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Subjects with Severe Hepatic Impairment Subjects with severe hepatic impairment (score of 10 to 15 on the Child-Pugh scale) will be administrated a 50-mg single oral dose of acalabrutinib. | Drug: acalabrutinib A 50-mg single oral dose of acalabrutinib will be administered. |
| Experimental: Matched-Control Subjects Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib. | Drug: acalabrutinib A 50-mg single oral dose of acalabrutinib will be administered. |
