An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
NCT ID: NCT01932528
Last Updated: 2013-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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500 mg LX606
All subjects will receive a single oral 500 mg dose of \[14C\]-LX1606.
500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.
Interventions
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500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
65 Years
MALE
Yes
Sponsors
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Lexicon Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Doug Fleming, MD
Role: STUDY_DIRECTOR
Lexicon Pharmaceuticals, Inc.
Locations
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Lexicon Investigational Site
Nottingham, , United Kingdom
Countries
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Other Identifiers
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LX1606.1-104-NRM
Identifier Type: -
Identifier Source: org_study_id