A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan

Bausch Health Americas, Inc.1 site in 1 country54 target enrollmentMarch 2006

ConditionsHealthy Adults

InterventionsSC Methylnaltrexone (MNTX)IV Methylnaltrexone (MNTX)Oral Paroxetine SC Placebo

DrugsSC Methylnaltrexone (MNTX)IV Methylnaltrexone (MNTX)Oral Paroxetine SC Placebo

Overview

Phase: Phase 1
Intervention: SC Methylnaltrexone (MNTX)
Conditions: Healthy Adults
Sponsor: Bausch Health Americas, Inc.
Enrollment: 54
Locations: 1
Primary Endpoint: Plasma Concentration of MNTX
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

August 2006

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bausch Health Americas, Inc.

Eligibility Criteria

Inclusion Criteria

•Healthy males between the ages of 18 and 55
•Non-Smokers
•Body weight range form 154-220 lbs
•No history of clinically significant metabolic disorders.

Exclusion Criteria

•Any history of low CYP450 2D6 activity
•History of alcohol abuse or recreational drugs
•History of any clinically significant disease or condition affecting a major organ system
•Donation or loss of blood, 60 days proceeding to screening visit.