drugset / Trial / NCT03423446

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

NCT03423446

Phase 1 Completed 16 enrolled Lexicon Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-11-28
Primary completion
2018-06-15
Completion
2018-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Telotristat Ethyl Unknown 250 mg

Indications

No indication recorded.