An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males (LX1606-104)

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

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

Study Overview

• Status: Completed
• Conditions: Carcinoid Syndrome
• Intervention / Treatment: Drug: 500 mg [14C]-LX1606

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Lexicon Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 500 mg LX606; All subjects will receive a single oral 500 mg dose of [14C]-LX1606.	Drug: 500 mg [14C]-LX1606; 500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration of LX1606 and LX1033	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Metabolic profiling and identification in feces	7 days

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals
• Investigators: Study Director: Doug Fleming, MD, Lexicon Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: August 27, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 30, 2013

Study Record Updates

• Last Update Posted (Estimate): October 23, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Absorption; Metabolism; Excretion
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Drug-Related Side Effects and Adverse Reactions; Carcinoid Tumor; Malignant Carcinoid Syndrome; Serotonin Syndrome
• Other Study ID Numbers: LX1606.1-104-NRM