Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

ClinicalTrials.gov ID: NCT01367483

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Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01367483
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Bausch Health Americas, Inc.; Industry
Enrollment: 6 participants

Conditions and interventions

Conditions

Healthy Male Volunteers

Interventions

IV methylnaltrexone (MNTX) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Male
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 2005 (Type not available)
Primary completion: Jun 2005 (Actual)
Completion: Jun 2005 (Actual)
Last update posted: Nov 27, 2019

2005

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Progenics Pharmaceuticals, Inc.	Tarrytown	New York	10591	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01367483, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 27, 2019 · Synced Nov 14, 2026