Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat
NCT02922946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2018-08-16
Summary
The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects.
Conditions
- Volunteers
- Healthy Volunteers
- Human Volunteers
- Normal Volunteers
Interventions
- DRUG
-
Entinostat
HDAC (histone deacetylase) inhibitor
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Laura Sterling, MD · Celerion
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-11
- Primary Completion
- 2017-05-20
- Completion
- 2017-06-26
Countries
- United States
Study Locations
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