NCT02922946

Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat

A 2-Stage, Open-Label, Randomized, Single-Dose, Crossover Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Syndax Pharmaceuticals · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a 2-stage food effect (timing of the meal) study. A total of 48 subjects will be dosed if Stage 2 is conducted. Stage 1 will be conducted as an open-label, randomized, 2-way crossover study. On Day 1 of each period, subjects will receive a single, oral dose of entinostat under fasting or fed conditions. If preliminary results in Stage 1 indicate that the timing of a meal exhibits significant effect on the bioavailability of entinostat, then Stage 2 will be conducted which will investigate the effect of a meal either before or after dosing of entinostat on entinostat PK. Stage 2 will be conducted as an open-label, randomized, 3-way crossover study. On Day 1 of each period, subjects will receive a single, oral dose of entinostat under fasting or fed conditions.

Conditions

• Volunteers
• Healthy Volunteers
• Human Volunteers
• Normal Volunteers

Interventions

Type	Name	Description
DRUG	Entinostat	HDAC (histone deacetylase) inhibitor

Timeline

• Start date: 2016-10-11
• Primary completion: 2017-05-20
• Completion: 2017-06-26
• First posted: 2016-10-04
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States