NCT05140096

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effect of fluconazole and isavuconazole on the PK of acalabrutinib and its active metabolite, ACP-5862.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2020-01-03
• Primary completion: 2020-04-15
• Completion: 2020-04-15
• First posted: 2021-12-01
• Last updated: 2021-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study