NCT04914936

A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196

A Phase 1, Single-Center, Open-Label, Fixed-Sequence, 2-Period, 3-Part Study to Evaluate the One-Way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on ACP-196.

Detailed description

This is a 3-part study. Each part will be conducted as an open-label, 2-period, fixed-sequence study. All the study parts will be conducted concurrently and the participants will receive the study treatment in all the parts after an overnight fast. In each part, 24 healthy, non-tobacco using, men and women will be enrolled, to ensure 22 participants complete each part. Each participant will participate in only one study part. In Part 1, a single oral dose of ACP-196 100 mg capsule will be administered on Day 1 of Period 1 (Treatment A), and a single oral dose of calcium carbonate 1 g tablets will be coadministered with a single oral dose of ACP-196 100 mg on Day 1 of Period 2 (Treatment B). In Part 2, a single oral dose of ACP-196 100 mg capsule will be administered on Day 1 pf Period 1 (Treatment C) and oral doses of omeprazole 40 mg capsules once daily (QD) for 5 consecutive days with a single oral dose of ACP-196 100 mg capsule coadministered on Day 5 of Period 2 (Treatment D). In Part 3, a single oral dose of ACP-196 will be administered on Day 1 of Period 1 (Treatment E) and oral dose of rifampin 600 mg capsule QD for 9 consecutive days with a single oral dose of ACP-196 100 mg capsule coadministered on Day 1 and Day 9. Participants will be screened within 28 days before the dose. There will be no washout between the dose in Period 1 and the first dose in Period 2. Participants will be contacted approximately 14 days after the last dose of study drug for adverse events.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	ACP-196	Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 in Part 1, Part 2, and Part 3; and on Day 1 of Period 2 in Part 1, Day 5 of Period 2 in Part 2, and Day 1 and Day 9 of Period 2 in Part 3.
DRUG	Calcium carbonate	Participants will receive a single oral dose of calcium carbonate 1 g tablet on Day 1 of Period 2 in Part 1.
DRUG	Omeprazole	Participants will receive multiple oral doses of omeprazole 40 mg capsules QD for 5 consecutive days in Period 2 of Part 2.
DRUG	Rifampin	Participants will receive multiple oral doses of rifampin 600 mg capsule QD for 9 consecutive days in Period 2 of Part 3.

Timeline

• Start date: 2014-09-21
• Primary completion: 2014-10-16
• Completion: 2014-10-16
• First posted: 2021-06-07
• Last updated: 2021-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study