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

A Phase 1, Single-center, Open-label, Fixed-sequence, 4-period, 3-part Study in Healthy Adult Subjects to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics of Acalabrutinib Alone and Coadministered With Omeprazole

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.

Detailed description

This is a 3-part study. Each part of the study will compare the effect of an acidic formulation of ACP-196, acidic beverage (orange drink), or grapefruit juice on the PK profile of ACP-196 alone and when coadministered with omeprazole. Participants will be enrolled into Part 1 of the study first and then subsequent participants will be randomized in a 1:1 ratio to either Part 2 or Part 3 of the study. Participants will be screened within 28 days before the dose. Participants will be contacted approximately 14 days after the last dose of study drug administration to determine if any adverse event has occurred since the last dose of study drug.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-28
• Primary completion: 2016-03-15
• Completion: 2016-03-15
• First posted: 2021-05-07
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study