NCT01366365

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

A Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	methylnaltrexone
DRUG	placebo

Timeline

• Start date: 2006-10-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2011-06-06
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States