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Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367535
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
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.

Condition Intervention Phase
Healthy Adults Drug: SC Methylnaltrexone (MNTX) Drug: IV Methylnaltrexone (MNTX) Drug: Oral Paroxetine Drug: SC Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 54
Study Start Date: March 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: SC Methylnaltrexone (MNTX)
Experimental: Arm 2 Drug: IV Methylnaltrexone (MNTX)
Active Comparator: Arm 3 Drug: Oral Paroxetine
Placebo Comparator: Arm 4 Drug: SC Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367535


Locations
United States, New York
Progenics Pharmaceuticals
Tarrytown, New York, United States, 10591
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
  More Information

Responsible Party: Tage Ramakrishna, M.D.;, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367535     History of Changes
Other Study ID Numbers: MNTX 1108
First Submitted: May 27, 2011
First Posted: June 7, 2011
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Paroxetine
Dextromethorphan
Methylnaltrexone
Naltrexone
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents