Back to resultsAn Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males (LX1606-104)
Primary Purpose
Carcinoid Syndrome
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
500 mg [14C]-LX1606
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoid Syndrome focused on measuring Absorption, Metabolism, Excretion
Eligibility 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
Sites / Locations
- Lexicon Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
500 mg LX606
Arm Description
All subjects will receive a single oral 500 mg dose of [14C]-LX1606.
Outcomes
Primary Outcome Measures
Maximum plasma concentration of LX1606 and LX1033
Secondary Outcome Measures
Time to maximum plasma concentration of and LX1033
Determination of total radioactivity in blood and plasma
Mass balance recovery of total radioactivity in urine and feces
Metabolite profiling and identification in plasma
Metabolic profiling and identification in urine
Metabolic profiling and identification in feces
Full Information
NCT ID
NCT01932528
First Posted
August 27, 2013
Last Updated
October 22, 2013
Sponsor
Lexicon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01932528
Brief Title
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Acronym
LX1606-104
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lexicon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoid Syndrome
Keywords
Absorption, Metabolism, Excretion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
500 mg LX606
Arm Type
Experimental
Arm Description
All subjects will receive a single oral 500 mg dose of [14C]-LX1606.
Intervention Type
Drug
Intervention Name(s)
500 mg [14C]-LX1606
Intervention Description
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.
Primary Outcome Measure Information:
Title
Maximum plasma concentration of LX1606 and LX1033
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Time to maximum plasma concentration of and LX1033
Time Frame
7 days
Title
Determination of total radioactivity in blood and plasma
Time Frame
7 days
Title
Mass balance recovery of total radioactivity in urine and feces
Time Frame
7 days
Title
Metabolite profiling and identification in plasma
Time Frame
7 days
Title
Metabolic profiling and identification in urine
Time Frame
7 days
Title
Metabolic profiling and identification in feces
Time Frame
7 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Fleming, MD
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Lexicon Investigational Site
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
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