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OpenTrials
Completed

NCT Number: NCT01367483

Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.

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Key information

Conditions

Healthy Male Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males between 18-45
  • Subject weight between 70 and 90 kg
  • In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion criteria

  • History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
  • Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
  • History of or predisposition to erratic or abnormal bowel function.

Treatment and study plan

IV Methylnaltrexone (MNTX)

Drug

Primary outcomes

  1. Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX

    Time frame: 5.5 days

    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

Secondary outcomes

  1. Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX

    Time frame: 5.5 Days

    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  2. Clearance of IV MNTX

    Time frame: 5.5 days

    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  3. Half-life of IV MNTX

    Time frame: 5.5 days

    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  4. Volume of Distribution of IV MNTX

    Time frame: 5.5 days

    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  5. Urinary Clearance of IV MNTX

    Time frame: 5.5 days

    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

An Open-Label, Phase I, Single Dose Study of the Pharmacokinetics, Mass Balance and Disposition of Intravenously Administered 14C-Methylnaltrexone in Normal, Healthy Volunteers

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jun 7, 2011
Registry last updated
Nov 27, 2019

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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