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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. Identifier: NCT01932528
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):
Lexicon Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Carcinoid Syndrome Drug: 500 mg [14C]-LX1606 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : September 2013

Arm Intervention/treatment
Experimental: 500 mg LX606
All subjects will receive a single oral 500 mg dose of [14C]-LX1606.
Drug: 500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.

Primary Outcome Measures :
  1. Maximum plasma concentration of LX1606 and LX1033 [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Time to maximum plasma concentration of and LX1033 [ Time Frame: 7 days ]
  2. Determination of total radioactivity in blood and plasma [ Time Frame: 7 days ]
  3. Mass balance recovery of total radioactivity in urine and feces [ Time Frame: 7 days ]
  4. Metabolite profiling and identification in plasma [ Time Frame: 7 days ]
  5. Metabolic profiling and identification in urine [ Time Frame: 7 days ]
  6. Metabolic profiling and identification in feces [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01932528

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United Kingdom
Lexicon Investigational Site
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Lexicon Pharmaceuticals
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Study Director: Doug Fleming, MD Lexicon Pharmaceuticals, Inc.
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Responsible Party: Lexicon Pharmaceuticals Identifier: NCT01932528    
Other Study ID Numbers: LX1606.1-104-NRM
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013
Keywords provided by Lexicon Pharmaceuticals:
Additional relevant MeSH terms:
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Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders