NCT01367496

Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose

An Open-Label, Phase I Study of the Pharmacokinetics and Bioavailability of Single, Ascending Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose in Normal, Healthy Male Volunteers

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

Summary

This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SC Methylnaltrexone (MNTX)	Dose 1
DRUG	SC Methylnaltrexone (MNTX)	Dose 2
DRUG	SC Methylnaltrexone (MNTX)	Dose 3
DRUG	IV Methylnaltrexone (MNTX)

Timeline

• Start date: 2002-06-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2011-06-07
• Last updated: 2019-11-27

Locations

1 site across 1 country: United States