Loading clinical trials...

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

COMPLETEDPHASE1

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

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

NCT01932528•Lexicon Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

30 - 65 years

Sex

MALE

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

Locations (1)

Lexicon Investigational Site

Nottingham, United Kingdom

Key Dates

Start Date

August 1, 2013

Primary Completion Date

September 1, 2013

Last Updated

October 23, 2013

Enrollment

ACTUAL participants

Conditions

Carcinoid Syndrome

Interventions

500 mg [14C]-LX1606

DRUG

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

NCT07087054

Carcinoid SyndromeCarcinoid+7 more

View study

TERMINATEDNA

Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

NCT04073017

Neuroendocrine TumorCarcinoid Syndrome

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Enterade in Carcinoid/Non-Carcinoid Syndrome Neuroendocrine Tumor Patients With Quality of Life Limiting Bowel Frequency

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

Study of Panitumumab in the Treatment of Carcinoid Syndrome

Effects of Serotonin Excess on Bone in Carcinoid Syndrome