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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01932528
First received: August 27, 2013
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Maximum plasma concentration of LX1606 and LX1033 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to maximum plasma concentration of and LX1033 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Determination of total radioactivity in blood and plasma [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Mass balance recovery of total radioactivity in urine and feces [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Metabolite profiling and identification in plasma [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Metabolic profiling and identification in urine [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Metabolic profiling and identification in feces [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: August 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932528

Locations
United Kingdom
Lexicon Investigational Site
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Doug Fleming, MD Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01932528     History of Changes
Other Study ID Numbers: LX1606.1-104-NRM
Study First Received: August 27, 2013
Last Updated: October 22, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Lexicon Pharmaceuticals:
Absorption
Metabolism
Excretion

Additional relevant MeSH terms:
Malignant Carcinoid Syndrome
Serotonin Syndrome
Carcinoid Tumor
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 01, 2014