An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Phase 1
Completed
- Conditions
- Carcinoid Syndrome
- Interventions
- Drug: 500 mg [14C]-LX1606
- Registration Number
- NCT01932528
- Lead Sponsor
- Lexicon Pharmaceuticals
- Brief Summary
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 500 mg LX606 500 mg [14C]-LX1606 All subjects will receive a single oral 500 mg dose of \[14C\]-LX1606.
- Primary Outcome Measures
Name Time Method Maximum plasma concentration of LX1606 and LX1033 7 days
- Secondary Outcome Measures
Name Time Method Time to maximum plasma concentration of and LX1033 7 days Determination of total radioactivity in blood and plasma 7 days Mass balance recovery of total radioactivity in urine and feces 7 days Metabolite profiling and identification in plasma 7 days Metabolic profiling and identification in urine 7 days Metabolic profiling and identification in feces 7 days
Trial Locations
- Locations (1)
Lexicon Investigational Site
🇬🇧Nottingham, United Kingdom