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Completed

NCT Number: NCT01932528

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

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

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Key information

Conditions

Carcinoid Syndrome Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Serotonin Syndrome

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Lexicon Investigational Site

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500 mg [14C]-LX1606

Drug

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

Primary outcomes

  1. Maximum plasma concentration of LX1606 and LX1033

    Time frame: 7 days

Secondary outcomes

  1. Time to maximum plasma concentration of and LX1033

    Time frame: 7 days

  2. Determination of total radioactivity in blood and plasma

    Time frame: 7 days

  3. Mass balance recovery of total radioactivity in urine and feces

    Time frame: 7 days

  4. Metabolite profiling and identification in plasma

    Time frame: 7 days

  5. Metabolic profiling and identification in urine

    Time frame: 7 days

  6. Metabolic profiling and identification in feces

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: LX1606-104

Important dates

Study start
2013
Primary completion
2013
First posted
Aug 30, 2013
Registry last updated
Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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