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An Open-Label Food Effect Study of Telotristat Etiprate

NCT02157584 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-09-08

No results posted yet for this study

Summary

This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy adult male and female subjects.

Conditions

  • Healthy

Interventions

DRUG

Telotristat etiprate

2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)

DRUG

Telotristat etiprate

2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157584 on ClinicalTrials.gov