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Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment

NCT03423446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-10-15

No results posted yet for this study

Summary

This study is designed to evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of telotristat ethyl (TE) ( LP-778902 active moiety, metabolite), following administration of a single dose of TE 250 mg (1 x 250-mg tablet) compared to healthy, demographically-matched subjects with normal hepatic function.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Telotristat Ethyl

Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2018-06-15
Completion
2018-06-15
FDA Drug
Yes

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 NCT03423446 on ClinicalTrials.gov