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

Lexicon Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Carcinoid Syndrome

Treatments: Drug: 500 mg [14C]-LX1606

Study type: Interventional

Funder types: Industry

Identifiers

NCT01932528

LX1606.1-104-NRM

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

500 mg LX606

Experimental group

Description:

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

Treatment:

Drug: 500 mg [14C]-LX1606