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

• Status: Completed
• Trial end date: 2019-03-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Acerta Pharma BV
• Collaborator: AstraZeneca
• Treatments: Acalabrutinib

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.