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NCT03968848 Clinical Trial

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

Healthy Subjects Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03968848
Other study ID # ACE-HI-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 12, 2018
Est. completion date March 29, 2019

Study information
Verified date July 2021
Source Acerta Pharma BV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date March 29, 2019
Est. primary completion date March 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria - Women must be of non childbearing status - Understands the study procedures in the ICF and be willing and able to comply with the protocol. - Willingness and ability to swallow study drug capsule. - Adult men or women, 18 to 75 years of age Hepatic-Impaired Subjects Only: - Subject has a diagnosis of chronic, stable HI. - Subject's score on the Child-Pugh scale must range from 10 to 15 at screening. Exclusion Criteria - History or presence of clinically significant or unstable medical or psychiatric condition or disease in the opinion of the PI. - Dosed in another clinical trial within 28 days before dosing of study drug and throughout the current study. - History or presence of drug abuse within 2 years before screening.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• acalabrutinib
A 50-mg single oral dose of acalabrutinib will be administered.

Locations
Country Name City State
United States Research Site Knoxville Tennessee
United States Research Site Miami Florida
United States Research Site Orlando Florida

Sponsors (2)
Lead Sponsor Collaborator
Acerta Pharma BV AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma Acalabrutinib PK Parameters Area Under the Concentration-Time Curve 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.
Primary Maximum Plasma Acalabrutinib Concentration Maximum Cmax 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.
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