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

Acerta Pharma

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Subjects; Hepatic Insufficiency

Treatments: Drug: acalabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03968848

ACE-HI-102

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Subjects with Severe Hepatic Impairment

Experimental group

Description:

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.

Treatment:

Drug: acalabrutinib

Matched-Control Subjects

Experimental group

Description:

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

Treatment:

Drug: acalabrutinib