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
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This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.
This is a 2-period study. On Day 1 of Period 1, all participants will be randomized to 1 of 2 treatment sequences and will receive a single oral dose of 100 mg acalabrutinib (Treatment A). In Period 2, the participants who participated in Period 1 will receive either Treatment B (fluconazole) or Treatment C (isavuconazole). In Period 2 Treatment B, participants will receive a single oral loading dose of 400 mg fluconazole on Day 1 one hour before a single oral dose of 100 mg acalabrutinib. In Period 2 Treatment C, participants will receive oral dose of 200 mg isavuconazole three times daily (TID; approximately 8 hours apart) on Day 1 and 200 mg isavuconazole once daily (QD) from Day 2 to Day 5 with a single oral dose of 100 mg acalabrutinib coadministered on Day 5. There will be a washout of at least 8 days between Period 1 and first dose in Period 2. All participants will return to the study site approximately 7 days after the last study drug for follow-up procedures and adverse event.
Location
Location
Tempe, Arizona, United States, 85283
Arms | Assigned Interventions |
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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). |
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