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

Launched by ACERTA PHARMA BV · May 29, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.