An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lexicon Pharmaceuticals

Criteria

Inclusion Criteria:

• Healthy male subjects aged 30 to 65 years of age.

• Male subjects and their partners must agree to use an adequate method of contraception

• Historically able to produce a minimum of 1 bowel movement every day on most days

Exclusion Criteria:

• Female subjects

• Use of any medication or supplement within 5 days prior to Dosing

• Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years

• Current smokers or the use of cigarettes within 90 days prior to Screening

• History or renal disease or abnormal kidney function

• History of hepatic disease

• Acute diarrhea or constipation within 7 days of dosing

• Positive urine glucose at Screening