Clinical Trial: An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects
Brief Summary: To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
Detailed Summary:
Sponsor: Lexicon Pharmaceuticals
Current Primary Outcome: Maximum plasma concentration of LX1606 and LX1033 [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to maximum plasma concentration of and LX1033 [ Time Frame: 7 days ]
- Determination of total radioactivity in blood and plasma [ Time Frame: 7 days ]
- Mass balance recovery of total radioactivity in urine and feces [ Time Frame: 7 days ]
- Metabolite profiling and identification in plasma [ Time Frame: 7 days ]
- Metabolic profiling and identification in urine [ Time Frame: 7 days ]
- Metabolic profiling and identification in feces [ Time Frame: 7 days ]
Original Secondary Outcome: Same as current
Information By: Lexicon Pharmaceuticals
Dates:
Date Received: August 27, 2013
Date Started: August 2013
Date Completion:
Last Updated: October 22, 2013
Last Verified: October 2013
