drugset / Trial / NCT01367496

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

NCT01367496

Phase 1 Completed 6 enrolled Bausch Health Americas, Inc.
Non-randomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2002-06
Primary completion
2002-08
Completion
2002-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylnaltrexone Other / unclassified Subcutaneous

Indications

No indication recorded.