Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite

Phase 1

Completed

• Conditions: Healthy Subjects; Hepatic Impairment; Hepatic Insufficiency
• Interventions: Drug: acalabrutinib

• Registration Number: NCT03968848
• Lead Sponsor: Acerta Pharma BV

Brief Summary

This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-12
• Primary Completion: 2019-03-13
• Study Completion: 2019-03-29
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-30
• Results First Submitted: 2021-04-09
• Status Verified: 2021-07
• Results First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Results First Posted: 2021-09-10
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matched-Control Subjects	acalabrutinib	Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib.
Subjects with Severe Hepatic Impairment	acalabrutinib	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.

Primary Outcome Measures

Name	Time	Method
Plasma Acalabrutinib PK Parameters	Severe HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 60, 72 hrs post-dose. Normal HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs post-dose.	Area Under the Concentration-Time Curve
Maximum Plasma Acalabrutinib Concentration	Severe HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 60, 72 hrs post-dose. Normal HI: pre-dose, and 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 hrs post-dose.	Maximum Cmax

Trial Locations

Locations (1)

Research Site; 🇺🇸 Knoxville, Tennessee, United States