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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2019-03-29

Brief Summary

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

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Detailed Description

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Conditions

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Hepatic Impairment Hepatic Insufficiency Healthy Subjects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

acalabrutinib

Intervention Type DRUG

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

Matched-Control Subjects

Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib.

Group Type EXPERIMENTAL

acalabrutinib

Intervention Type DRUG

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

Interventions

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acalabrutinib

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes