Trials / Completed
CompletedNCT02155205
A Thorough QT Study of Telotristat Etiprate
Randomized, Double-blind, Placebo-controlled, Positive Controlled, 3-period, 6-sequence, Crossover Study to Define the Electrocardiogram Effects of a Single Dose of Telotristat Etiprate (LX1606) 1500 mg Compared With Placebo and Open Label Moxifloxacin in Healthy Subjects: A Thorough QT Study
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Lexicon Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate that telotristat etiprate does not differ from placebo in the mean change from Baseline QT interval corrected for heart rate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telotristat etiprate | 1500 mg telotristat etiprate (six 250 mg tablets) |
| DRUG | Placebo | Matching placebo |
| DRUG | Moxifloxacin | 400 mg moxifloxacin (one 400 mg tablet) |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2014-08-01
- First posted
- 2014-06-04
- Last updated
- 2014-09-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02155205. Inclusion in this directory is not an endorsement.