Phase 1 N=16 Treatment

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

Hepatic Impairment · Hepatic Insufficiency · Healthy Subjects

Bottom Line

View on ClinicalTrials.gov: NCT03968848 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Plasma Acalabrutinib PK Parameters — 1167; 226.1; 1161; 220.0 ng*hr/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: acalabrutinib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Acerta Pharma BV
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Acalabrutinib PK Parameters	1167; 226.1; 1161; 220.0; 1169; 226.5	—
PRIMARY Maximum Plasma Acalabrutinib Concentration	726.0; 147.7	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03968848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.