NCT01366339

Tolerance and Pharmacokinetics Study of MNTX Tablets

A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.

Conditions

• Normal Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Oral methylnaltrexone
DRUG	Oral placebo

Timeline

• Start date: 2003-10-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2011-06-06
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States