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

May 27, 2011
July 17, 2011
March 2006
August 2006   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01367535 on ClinicalTrials.gov Archive Site
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.
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01367535
MNTX 1108
No
Tage Ramakrishna, M.D.;, Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
Not Provided
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
July 2011

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