Study identifier:ACE-HI-001
ClinicalTrials.gov identifier:NCT04867941
EudraCT identifier:N/A
CTIS identifier:N/A
A 2-Part, Open-Label, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of ACP-196
Hepatic insufficiency
Phase 1
Yes
ACP-196
All
18
Interventional
18 Years - 75 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2021 by Acerta Pharma BV
Acerta Pharma BV
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The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.
This is a 2-part study. Part 1 of the study will compare the PK of ACP-196 in participants with mild hepatic insufficiency (a score of 5 to 6, on the Child-Pugh scale) and moderate hepatic insufficiency (a score of 7 to 9, on the Child-Pugh scale) to healthy (mean) matched control participants for age and weight. Part 2 of the study, if it is conducted, will compare the PK of ACP-196 in participants with severe hepatic insufficiency (a score of 10 to 15 on the Child-Pugh scale) to the healthy control participants from Part 1. In Part 1, 6 participants with mild hepatic insufficiency, 6 participants with moderate hepatic, and 6 healthy control participants matched to the hepatic insufficiency groups according to mean age and mean weight will be enrolled. In Part 2, if conducted, 6 participants with severe hepatic insufficiency will be enrolled. The control group of Part 1 will be used for Part 2 PK comparison. Participants will be screened within 28 days before the dose. Participants will be contacted approximately 14 days after the last dose of study drug administration to determine if any adverse event has occurred since the last dose of study drug.
Location
Location
Miami, Florida, United States, 33136
Location
Orlando, Florida, United States, 32809
Location
Knoxville, Tennessee, United States, 37920
Arms | Assigned Interventions |
---|---|
Experimental: Part1: Mild hepatic insufficiency Participants with mild hepatic insufficiency will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. | Drug: ACP-196 All study participants will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. Other Name: Acalabrutinib |
Experimental: Part 1: Moderate hepatic insufficiency Participants with moderate hepatic insufficiency will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. | Drug: ACP-196 All study participants will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. Other Name: Acalabrutinib |
Experimental: Part 1: Normal hepatic function Participants with normal hepatic function will receive a single oral dose of 50 mgACP-196 (2 x 25 mg capsules) on Day 1 of the study. | Drug: ACP-196 All study participants will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. Other Name: Acalabrutinib |
Experimental: Part 2: Severe hepatic insufficiency Participants with sever hepatic insufficiency will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. | Drug: ACP-196 All study participants will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study. Other Name: Acalabrutinib |
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