A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and its Active Metabolite (ACP-5862) when Administered Alone and With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole in Healthy Adult Participants

Study identifier:ACE-HV-114

ClinicalTrials.gov identifier:NCT05140096

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Fixed Sequence Study in Healthy Subjects to Assess the Pharmacokinetics of Acalabrutinib and its Active Metabolite, ACP-5862, When Administered Alone and in Combination With Moderate CYP3A4 Inhibitors Fluconazole or Isavuconazole

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Acalabrutinib, Fluconazole, Isavuconazole

Sex

All

Actual Enrollment

30

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 03 Jan 2020
Primary Completion Date: 15 Apr 2020
Study Completion Date: 15 Apr 2020

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2021 by Acerta Pharma BV

Sponsors

Acerta Pharma BV

Collaborators

-

Inclusion and exclusion criteria