CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
acalabrutinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03968848
NCT03968848Phase 1Completed
CompareCT.gov

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)

Acerta Pharma BV·interventional·Posted May 30, 2019·Updated Sep 10, 2021

In Brief

A Phase 1 clinical trial evaluating acalabrutinib for Hepatic Impairment and 2 related conditions. Completed, enrolled 16 participants across 3 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment, Hepatic Insufficiency, Healthy Subjects
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 30, 2019
Enrollment StartNov 12, 2018
Primary CompletionMar 13, 2019
Study CompletionMar 29, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.1 years ago

Interventions

acalabrutinibdrug

A 50-mg single oral dose of acalabrutinib will be administered.