NCT02147808

A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects

A Phase 1, Open-Label, Single-Center, 2-Period, Single-Sequence Drug-Drug Interaction Study to Evaluate the Effects of Multiple-Dose Telotristat Etiprate on the Pharmacokinetics of Single-Dose Midazolam, a Sensitive P450-3A4 Substrate, in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Telotristat etiprate	All subjects will receive two 250 mg telotristat etiprate tablets three times daily.
DRUG	Midazolam	All subjects will receive 3 mg (1.5 mL oral syrup \[2mg/mL\]).

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-08-01
• First posted: 2014-05-28
• Last updated: 2014-09-08

Locations

1 site across 1 country: United States