A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
NCT04914936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2021-06-07
Summary
The study will evaluate one-way interaction of calcium carbonate, omeprazole, or rifampin on ACP-196.
Conditions
- Healthy Participants
Interventions
- 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
-
Participants will receive multiple oral doses of rifampin 600 mg capsule QD for 9 consecutive days in Period 2 of Part 3.
Sponsors & Collaborators
-
Acerta Pharma BV
lead INDUSTRY
Principal Investigators
-
Ahmed Hamdy, MD · Acerta Pharma BV
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-09-21
- Primary Completion
- 2014-10-16
- Completion
- 2014-10-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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