NCT01932528

CompletedPhase 1

An Open-label Study to Evaluate the Absorption, Metabolism, ...

Lexicon Pharmaceuticals Source

Lexicon Pharmaceuticals

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

LX1606.1-104-NRM

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2013

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 27, 2013
Actual (reported)
First Posted
August 30, 2013
Actual (reported)
Primary Completion
September 2013
Actual (reported)

Last Updated: October 23, 2013
Status Verified: October 2013
Last Update Submitted: October 22, 2013

Conditions

Carcinoid Syndrome

Keywords

AbsorptionMetabolismExcretion

Outcome Measures

Primary Outcomes (1)

Maximum plasma concentration of LX1606 and LX1033
7 days

Secondary Outcomes (6)

Time to maximum plasma concentration of and LX1033
7 days
Determination of total radioactivity in blood and plasma
7 days
Mass balance recovery of total radioactivity in urine and feces
7 days
Metabolite profiling and identification in plasma
7 days
Metabolic profiling and identification in urine
7 days
+1 more secondary outcomes

Study Arms (1)

500 mg LX606

EXPERIMENTAL

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

Drug: 500 mg [14C]-LX1606

Interventions

500 mg [14C]-LX1606Drug

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

500 mg LX606

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years - 65 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Healthy male subjects aged 30 to 65 years of age.
Male subjects and their partners must agree to use an adequate method of contraception

Sponsors & Collaborators

Lexicon Pharmaceuticals
Industrylead

Study Sites (1)

Lexicon Investigational Site

Nottingham, NG11 6JS, United Kingdom

MeSH Terms

Conditions

Serotonin Syndrome

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Study Officials

Doug Fleming, MD
Lexicon Pharmaceuticals, Inc.
STUDY DIRECTOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

August 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT00853047

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

Phase 2Completed

NCT01430871

Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Completed

NCT01172717

Study of Panitumumab in the Treatment of Carcinoid Syndrome

Phase 2Withdrawn

NCT03223428

Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

Completed

NCT01018953

Study to Assess the Efficacy and Safety of Different Doses of BIM 23A760 in Patients With Carcinoid Syndrome

Phase 2Terminated

NCT00884715

Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Phase 1/2Terminated

Historically able to produce a minimum of 1 bowel movement every day on most days

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

September 2013

Actual (reported)

Last Updated

October 23, 2013

Record last verified: 2013-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT01932528
Data provider: ClinicalTrials.gov
Source updated: 2013-10-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:51 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

500 mg LX606

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations