A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, Food Effects, and Drug-drug Interactions of ACP-196 in Healthy Participants
NCT04901923 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2021-05-26
Summary
This study is to evaluate the safety, pharmacokinetics/pharmacodynamics (PK/PD), food-effect, and drug-drug interaction study of ACP-196 in healthy participants.
Conditions
- Healthy Participants
Interventions
- DRUG
-
ACP-196
Participants will receive ACP-196 oral capsule(s) in all parts.
- DRUG
-
Itraconazole
Participants will receive itraconazole 200 mg capsules BID from Days 4 to 8 with meals and then 200 mg capsule QD on Day 9 under fasting state.
Sponsors & Collaborators
-
Acerta Pharma BV
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-03-15
- Primary Completion
- 2014-05-22
- Completion
- 2014-05-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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