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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 3, 2020

Primary Completion Date

April 15, 2020

Study Completion Date

April 15, 2020

Conditions
Healthy Volunteers
Interventions
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).

Trial Locations (1)

85283

Celerion, Tempe

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Acerta Pharma BV

INDUSTRY