NCT04488016 - A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 24, 2020

Primary Completion Date

January 20, 2021

Study Completion Date

January 20, 2021

Conditions

BioavailabilityB-cell Lymphoid Cancer

Interventions

DRUG

Treatment A- Part 1

Subjects will receive 100 mg acalabrutinib capsule, fasted state;

DRUG

Treatment B- Part 1

Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state

DRUG

Treatment C - Part 1

Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fed state

DRUG

Treatment D- Part 1

Subjects will receive Rabeprazole 20 mg QD (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1) and following prior administration of rabeprazole 20 mg Twice per day (BID) (with meals) on Days -3, -2 and -1.

DRUG

Treatment A-Part 2

Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state

DRUG

Treatment B - Part 2

Subjects will receive 100 mg acalabrutinib tablet (Variant 2), fasted state

DRUG

Treatment C - Part 2

Subjects will receive 100 mg acalabrutinib tablet (Variant 3), fasted state

DRUG

Treatment D - Part 2

Subjects will receive 100 mg acalabrutinib solution, (Variant 4), fasted state

Trial Locations (1)

21225

Research Site, Baltimore