Carcinoid Syndrome
Conditions
Keywords
Absorption, Metabolism, Excretion
Brief summary
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
Interventions
DRUG500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration of LX1606 and LX1033 | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Determination of total radioactivity in blood and plasma | 7 days |
| Mass balance recovery of total radioactivity in urine and feces | 7 days |
| Time to maximum plasma concentration of and LX1033 | 7 days |
| Metabolic profiling and identification in urine | 7 days |
| Metabolic profiling and identification in feces | 7 days |
| Metabolite profiling and identification in plasma | 7 days |
Countries
United Kingdom
Outcome results
None listed