NCT01367483

Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	IV methylnaltrexone (MNTX)

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2011-06-07
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States