Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
NCT02058784 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2017-02-23
Summary
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
Conditions
- Healthy Volunteers
- Moderate to Heavy Smokers
- Non-smokers
Interventions
- DRUG
-
pracinostat
Sponsors & Collaborators
-
Celerion
collaborator INDUSTRY -
Helsinn Healthcare SA
lead INDUSTRY
Principal Investigators
-
Terry E O'Reilly, MD · Celerion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2014-03-31
- Completion
- 2014-03-31
Countries
- United States
Study Locations
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