NCT03423446

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

A Phase 1, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Telotristat Ethyl in Male and Female Subjects With Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Telotristat Ethyl	Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose

Timeline

• Start date: 2017-11-28
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2018-02-06
• Last updated: 2018-10-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study