A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 28, 2016

Primary Completion Date

March 15, 2016

Study Completion Date

March 15, 2016

Conditions
Healthy Volunteers
Interventions
DRUG

ACP-196

In Parts 1, 2, and 3, participants will receive oral Dose 1 of ACP-196 (reference or acidic formulation as applicable) on Day 1, Day 3, Day 8, and Day 10.

DRUG

Omeprazole

Participants will receive omeprazole in all parts as: on Day 8 and Day 10 with water in Part 1; on Day 8 with water and on Day 10 with acidic beverage in Part 2; on Day 8 with water and on Day 10 with grapefruit juice in Part 3.

Trial Locations (1)

(402) 437-483

Laura Sterling, MD, MPH, Lincoln

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Acerta Pharma BV

INDUSTRY

NCT04876807 - A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole | Biotech Hunter | Biotech Hunter