NCT02157558

An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine 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 Fexofenadine, a Sensitive P Glycoprotein 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

The purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (PK) of single-dose fexofenadine in healthy subjects.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Fexofenadine	All subjects will receive 180 mg fexofenadine
DRUG	Telotristat etiprate	All subjects will receive 500 mg (2 X 250 mg tablets) telotristat etiprate tablets three times daily

Timeline

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

Locations

1 site across 1 country: United States