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

NCT03968848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-09-10

Study results available
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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

DRUG

acalabrutinib

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Acerta Pharma BV

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2019-03-13
Completion
2019-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03968848 on ClinicalTrials.gov