NCT00853047

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.

Conditions

• Carcinoid Syndrome

Interventions

Type	Name	Description
DRUG	Telotristat etiprate	Telotristat etiprate capsules; orally 3 times daily.
DRUG	Octreotide LAR Depot	A stable-dose octreotide LAR depot therapy; administered subcutaneously once per month.
DRUG	Placebo	Placebo-matching telotristat etiprate capsules; orally 3 times daily.

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2009-02-27
• Last updated: 2018-12-26
• Results posted: 2018-12-26

Locations

9 sites across 1 country: United States