NCT02155205

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

June 2, 2014

Last Update Submit

September 5, 2014

Conditions

QT Interval

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline QT interval corrected for heart rate

    Days 1-3

Secondary Outcomes (2)

  • Number of adverse events

    52 days

  • Plasma concentration of telotristat etiprate

    Day 1

Study Arms (3)

Telotristat etiprate

EXPERIMENTAL

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

Drug: Telotristat etiprate

Moxifloxacin

ACTIVE COMPARATOR

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

Drug: Moxifloxacin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Telotristat etiprateDRUG

1500 mg telotristat etiprate (six 250 mg tablets)

Telotristat etiprate
PlaceboDRUG

Matching placebo

Placebo
MoxifloxacinDRUG

400 mg moxifloxacin (one 400 mg tablet)

Moxifloxacin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

telotristatMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Suman Wason, MD

    Lexicon Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

US(1)