A Thorough QT Study of Telotristat Etiprate

NCT ID: NCT02155205

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

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.

Conditions

QT Interval

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Telotristat etiprate

Single dose of telotristat etiprate followed by a 7-day washout.

Group Type: EXPERIMENTAL

Telotristat etiprate

Intervention Type: DRUG

1500 mg telotristat etiprate (six 250 mg tablets)

Moxifloxacin

Single dose of moxifloxacin followed by a 7-day washout.

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

400 mg moxifloxacin (one 400 mg tablet)

Placebo

Single dose of placebo with a 7-day washout to follow.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

Telotristat etiprate

1500 mg telotristat etiprate (six 250 mg tablets)

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

Moxifloxacin

400 mg moxifloxacin (one 400 mg tablet)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lexicon Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Wason, MD

Role: STUDY_DIRECTOR

Lexicon Pharmaceuticals, Inc.

Locations

Lexicon Investigational Site

Evansville, Indiana, United States

Countries

United States

Other Identifiers

LX1606.105

Identifier Type: OTHER

Identifier Source: secondary_id

LX1606.1-105-NRM

Identifier Type: -

Identifier Source: org_study_id