NCT02157584

An Open-Label Food Effect Study of Telotristat Etiprate

A Phase 1, Randomized, Single Center, Open Label, 2 Sequence, 2 Period, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of Telotristat Etiprate (LX1606 Hippurate) in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Telotristat etiprate	2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)
DRUG	Telotristat etiprate	2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-07-01
• First posted: 2014-06-06
• Last updated: 2014-09-08

Locations

1 site across 1 country: United States