Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

A Phase 2, Open-Label, Multi-Center, Serial Ascending-Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome

The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.

Inclusion Criteria:

• Males and females, aged 18 and older
• Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
• Symptomatic carcinoid syndrome (≥4 bowel movements per day)
• Ability to provide written informed consent

Exclusion Criteria:

• ≥ 12 high-volume, watery bowel movements per day
• Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
• Karnofsky status ≤70% - unable to care for self
• Surgery within 60 days prior to screening
• A history of short bowel syndrome
• Life expectancy < 12 months
• History of substance or alcohol abuse within 2 years prior to screening
• Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening