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Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367535
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Plasma Concentration of MNTX [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367535

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

No publications provided

Responsible Party: Tage Ramakrishna, M.D.;, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367535     History of Changes
Other Study ID Numbers: MNTX 1108
Study First Received: May 27, 2011
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dextromethorphan
Methylnaltrexone
Naltrexone
Paroxetine
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
 Therapeutic Uses
Respiratory System Agents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013