NCT03968848

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Hepatic Impairment
• Hepatic Insufficiency
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	acalabrutinib	A 50-mg single oral dose of acalabrutinib will be administered.

Timeline

• Start date: 2018-11-12
• Primary completion: 2019-03-13
• Completion: 2019-03-29
• First posted: 2019-05-30
• Last updated: 2021-09-10
• Results posted: 2021-09-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study