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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatic Impairment Digestive System Diseases Healthy Subjects Hepatic Insufficiency Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Miami, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acalabrutinib

Drug

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

Primary outcomes

Plasma Acalabrutinib PK Parameters

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Acerta Pharma BV

Industry

Collaborators

AstraZeneca

Registry information

Official study 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)

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: May 30, 2019
Registry last updated: Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed