Study identifier:ACE-HV-114
ClinicalTrials.gov identifier:NCT05140096
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Volunteers
Phase 1
Yes
Acalabrutinib, Fluconazole, Isavuconazole
All
30
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2021 by Acerta Pharma BV
Acerta Pharma BV
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment AB Participants will receive a single oral dose 100 mg acalabrutinib capsule on Day 1 of Period 1 (Treatment A) and later will receive single oral loading dose of 400 mg fluconazole tablets on Day 1, one hour prior to a single oral dose of 100 mg acalabrutinib in Period 2 (Treatment B). | Drug: Acalabrutinib Modify as "Participants will receive a single oral dose of 100 mg (1 X 100 mg capsule) acalabrutinib either on Day 1 of Period 1 (Treatment A) and Day 1 of Period 2 (Treatment B) or Day 5 of Period 2 (Treatment C). Drug: Fluconazole Participants will receive 400 mg fluconazole (2 × 200 mg tablets) on Day 1 Period 2 (Treatment B). |
Experimental: Treatment AC Participants will receive a single oral dose 100 mg acalabrutinib capsule on Day 1 of Period 1 (Treatment A), and later will receive oral dose of 200 mg iscavuconazole capsules three times daily (approximately every 8 hours apart) on Day 1, followed by 200 mg iscavuconazole capsule once daily from Day 2 to Day 5 with a single oral dose of 100 mg acalabrutinib capsule coadministered on Day 5 in Period 2 (Treatment C). | Drug: Acalabrutinib Modify as "Participants will receive a single oral dose of 100 mg (1 X 100 mg capsule) acalabrutinib either on Day 1 of Period 1 (Treatment A) and Day 1 of Period 2 (Treatment B) or Day 5 of Period 2 (Treatment C). Drug: Isavuconazole Participant will receive oral dose of 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) three times daily on Day 1 and 200 mg isavuconazole (2 × 186 mg of isavuconazonium sulfate capsules) once daily on Days 2 to 5 in Period 2 (Treatment C). |