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

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)

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

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.