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

Completed · Phase 1

Conditions studied: Hepatic Impairment, Hepatic Insufficiency, Healthy Subjects

In brief

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

Key facts

Study ID

NCT03968848

Run by

Acerta Pharma BV

People needed

16

Starts

2018-11-12

Expected to finish

2019-03-29

Last updated by the study team

2021-09-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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