A Thorough QT Study of Telotristat Etiprate
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|ClinicalTrials.gov Identifier: NCT02155205|
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : September 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|QT Interval||Drug: Telotristat etiprate Drug: Placebo Drug: Moxifloxacin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 2014|
Experimental: Telotristat etiprate
Single dose of telotristat etiprate followed by a 7-day washout.
Drug: Telotristat etiprate
1500 mg telotristat etiprate (six 250 mg tablets)
Active Comparator: Moxifloxacin
Single dose of moxifloxacin followed by a 7-day washout.
400 mg moxifloxacin (one 400 mg tablet)
Placebo Comparator: Placebo
Single dose of placebo with a 7-day washout to follow.
- Mean change from baseline QT interval corrected for heart rate [ Time Frame: Days 1-3 ]
- Number of adverse events [ Time Frame: 52 days ]
- Plasma concentration of telotristat etiprate [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155205
|United States, Indiana|
|Lexicon Investigational Site|
|Evansville, Indiana, United States, 47710|
|Study Director:||Suman Wason, MD||Lexicon Pharmaceuticals, Inc.|