Skip to main content
OpenTrials
Completed

NCT Number: NCT01367535

Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Adults

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Progenics Pharmaceuticals

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SC Methylnaltrexone (MNTX)

Drug

IV Methylnaltrexone (MNTX)

Drug

Oral Paroxetine

Drug

SC Placebo

Drug

Primary outcomes

  1. Plasma Concentration of MNTX

    Time frame: 4 months

    The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.

Secondary outcomes

  1. Plasma Concentration of Paroxetine

    Time frame: 4 months

    The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jun 7, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.