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

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

Official Title
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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)

Conditions
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Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects

Intervention / Treatment
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* Drug: acalabrutinib


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Severe Hepatic Impairment<br>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. | Drug: acalabrutinib<br>* A 50-mg single oral dose of acalabrutinib will be administered.<br>|
| Experimental: Matched-Control Subjects<br>Subjects with normal hepatic function will be administrated a 50-mg single oral dose of acalabrutinib. | Drug: acalabrutinib<br>* A 50-mg single oral dose of acalabrutinib will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic, Acalabrutinib