NCT01932528

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

1 month

First QC Date

August 27, 2013

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Lexicon Investigational Site

Nottingham, NG11 6JS, United Kingdom

Location

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

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 1, 2013

Primary Completion

September 1, 2013

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

GB(1)