CompletedNCT01932528LX1606-104Updated Oct 23, 2013

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

A Phase 1 interventional study of 500 mg [14C]-LX1606 in Carcinoid Syndrome, sponsored by Lexicon Pharmaceuticals. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-23.

Sponsored by Lexicon Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 30 Years to 65 Years
Sex: Male

Study summary

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

Conditions studied

Carcinoid Syndrome

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Keywords

Absorption
Metabolism
Excretion

In context

Malignant Carcinoid Syndrome

59 studies on the registry are indexed under Malignant Carcinoid Syndrome; none are open to participants now.

This study's enrollment of 8 is below the median of 33 across 44 interventional studies indexed under Malignant Carcinoid Syndrome.

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Lead sponsor

Lexicon Pharmaceuticals is the lead sponsor of 60 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 65 Years
Sexes eligible: 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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
500 mg LX606
All subjects will receive a single oral 500 mg dose of \[14C\]-LX1606.
Drug: 500 mg [14C]-LX1606

Interventions

Drug500 mg [14C]-LX1606
500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as \[14C\]-LX1606.

What researchers measure

Primary outcomes

Maximum plasma concentration of LX1606 and LX1033
Time frame: 7 days

Secondary outcomes

Time to maximum plasma concentration of and LX1033
Time frame: 7 days
Determination of total radioactivity in blood and plasma
Time frame: 7 days
Mass balance recovery of total radioactivity in urine and feces
Time frame: 7 days
Metabolite profiling and identification in plasma
Time frame: 7 days
Metabolic profiling and identification in urine
Time frame: 7 days
Metabolic profiling and identification in feces
Time frame: 7 days

Study locations

1 site

Lexicon Investigational Site
Nottingham, NG11 6JS, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01932528
Lead sponsor: Lexicon Pharmaceuticals
Responsible party: Sponsor
First posted: Aug 30, 2013
Start date: Aug 2013
Primary completion: Sep 2013
Last update: Oct 23, 2013

Study contacts

Doug Fleming, MD

study director · Lexicon Pharmaceuticals, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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