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An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males (LX1606-104)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01932528
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE August 30, 2013
Last Update Posted Date October 23, 2013
Study Start Date  ICMJE August 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
Maximum plasma concentration of LX1606 and LX1033 [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2013)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoid Syndrome
Intervention  ICMJE Drug: 500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.
Study Arms  ICMJE Experimental: 500 mg LX606
All subjects will receive a single oral 500 mg dose of [14C]-LX1606.
Intervention: Drug: 500 mg [14C]-LX1606
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2013)
8
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01932528
Other Study ID Numbers  ICMJE LX1606.1-104-NRM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexicon Pharmaceuticals
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Doug Fleming, MD Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP