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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.
May 27, 2011
June 7, 2011
July 19, 2011
March 2006
August 2006   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01367535 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Adults
  • Drug: SC Methylnaltrexone (MNTX)
  • Drug: IV Methylnaltrexone (MNTX)
  • Drug: Oral Paroxetine
  • Drug: SC Placebo
  • Experimental: Arm 1
    Intervention: Drug: SC Methylnaltrexone (MNTX)
  • Experimental: Arm 2
    Intervention: Drug: IV Methylnaltrexone (MNTX)
  • Active Comparator: Arm 3
    Intervention: Drug: Oral Paroxetine
  • Placebo Comparator: Arm 4
    Intervention: Drug: SC Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
August 2006
August 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01367535
MNTX 1108
No
Not Provided
Not Provided
Tage Ramakrishna, M.D.;, Progenics Pharmaceuticals, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Valeant Pharmaceuticals International, Inc.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP