A Thorough QT Study of Telotristat Etiprate

QT Interval Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155205
• Other study ID #: LX1606.1-105-NRM
• Secondary ID: LX1606.105
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2014
• Last updated: September 5, 2014
• Start date: May 2014

Study information

• Verified date: September 2014
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• QT Interval

Intervention

Drug:
• Telotristat etiprate
1500 mg telotristat etiprate (six 250 mg tablets)
• Placebo
Matching placebo
• Moxifloxacin
400 mg moxifloxacin (one 400 mg tablet)

Locations

Country	Name	City	State
United States	Lexicon Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline QT interval corrected for heart rate		Days 1-3	Yes
Secondary	Number of adverse events		52 days	Yes
Secondary	Plasma concentration of telotristat etiprate		Day 1	No