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

Carcinoid Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932528
• Other study ID #: LX1606.1-104-NRM
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2013
• Last updated: October 22, 2013
• Start date: August 2013

Study information

• Verified date: October 2013
• Source: Lexicon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Syndrome
• Malignant Carcinoid Syndrome
• Serotonin Syndrome

Intervention

Drug:
• 500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.

Locations

Country	Name	City	State
United Kingdom	Lexicon Investigational Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Lexicon Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration of LX1606 and LX1033		7 days	No
Secondary	Time to maximum plasma concentration of and LX1033		7 days	No
Secondary	Determination of total radioactivity in blood and plasma		7 days	No
Secondary	Mass balance recovery of total radioactivity in urine and feces		7 days	No
Secondary	Metabolite profiling and identification in plasma		7 days	No
Secondary	Metabolic profiling and identification in urine		7 days	No
Secondary	Metabolic profiling and identification in feces		7 days	No