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A Thorough QT Study of Telotristat Etiprate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02155205
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
QT Interval Drug: Telotristat etiprate Drug: Placebo Drug: Moxifloxacin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Moxifloxacin
400 mg moxifloxacin (one 400 mg tablet)

Placebo Comparator: Placebo
Single dose of placebo with a 7-day washout to follow.
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Mean change from baseline QT interval corrected for heart rate [ Time Frame: Days 1-3 ]

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 52 days ]
  2. Plasma concentration of telotristat etiprate [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males or females ≥18 to ≤55 years of age (inclusive) at the time of Screening
  • Body mass index ≥18 to ≤32 kg/m2 at Screening
  • Vital signs (after at least 5 minutes resting in a supine position) at Screening which are within the following ranges: Systolic blood pressure 90 to 140 mm Hg, Diastolic blood pressure 50 to 90 mm Hg, heart rate 45 to 100 beats per minute (bpm)
  • Clinical laboratory evaluations (including clinical chemistry panel [fasted at least 10 hours], complete blood count, and urinalysis [UA]) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
  • Able to tolerate prolonged periods of quiet, motionless, supervised rest
  • Willing to adhere to the prohibitions and restrictions specified in this protocol
  • Able to comprehend and willing to sign an Informed Consent Form

Exclusion Criteria:

  • Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator or Sponsor, may interfere with any aspect of study conduct or interpretation of results
  • >30 premature ventricular beats per hour on the Holter ECG monitoring at Day -1 of Period 1 (monitored at the clinic via telemetry)
  • History of additional risk factors for torsade de pointes or the diagnosis or suggestion of a family history of short QT syndrome or long QT syndrome
  • History of renal disease or significantly abnormal kidney function tests
  • History of hepatic disease or significantly abnormal liver function tests
  • History of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, or gastrointestinal abnormality
  • Concurrent conditions that could interfere with safety and tolerability measurements
  • Positive hepatitis panel (including hepatitis B surface antigen and hepatitis C virus antibody) or positive human immunodeficiency virus antibody screens
  • Use of tobacco, use of medications, or history of any disease or condition that might interfere with the conduct of the study in the opinion of the investigator

Information from the National Library of Medicine

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


Locations
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United States, Indiana
Lexicon Investigational Site
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
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Study Director: Suman Wason, MD Lexicon Pharmaceuticals, Inc.
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Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02155205    
Other Study ID Numbers: LX1606.1-105-NRM
LX1606.105 ( Other Identifier: Lexicon Pharmaceuticals, Inc. )
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Moxifloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents