NCT02683577

Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects

A Phase 1, Open-label Study to Evaluate the Single Dose Pharmacokinetics of Telotristat Etiprate in Male and Female Subjects With Mild, Moderate and Severe Hepatic Impairment and Matched Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	telotristat etiprate

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-02-17
• Last updated: 2019-01-25
• Results posted: 2017-11-28

Locations

2 sites across 2 countries: Moldova, Romania