NCT02553356

PT2385-102 Food Effect Study of PT2385 in Healthy Volunteers

A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2385 Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase 1, single-dose study will be conducted in adult female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of PT2385 Tablets. The study will consist of two periods and will be conducted in a crossover fashion.

Detailed description

Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected for after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PT2385

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-09-17
• Last updated: 2015-12-10

Locations

1 site across 1 country: United States