Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: IV Methylnaltrexone (MNTX); Drug: SC Placebo; Drug: SC Methylnaltrexone (MNTX); Drug: Oral Paroxetine

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Tarrytown, New York, United States, 10591
      • Progenics Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: SC Methylnaltrexone (MNTX)
Experimental: Arm 2	Drug: IV Methylnaltrexone (MNTX)
Placebo Comparator: Arm 4	Drug: SC Placebo
Active Comparator: Arm 3	Drug: Oral Paroxetine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of MNTX	The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Paroxetine	The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.	4 months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Narcotic Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Alcohol Deterrents; Paroxetine; Naltrexone; Methylnaltrexone
• Other Study ID Numbers: MNTX 1108