A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 22, 2020

Primary Completion Date

June 26, 2020

Study Completion Date

June 26, 2020

Conditions
PharmacokineticsBioavailability
Interventions
DRUG

Acalabrutinib Treatment A

Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.

DRUG

Acalabrutinib Treatment B

Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.

DRUG

Acalabrutinib Treatment C

Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.

Trial Locations (1)

91206

Research Site, Glendale

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Acerta Pharma, LLC

OTHER

lead

AstraZeneca

INDUSTRY