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Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01367535
Collaborator
(none)
54
Enrollment
1
Location
4
Arms
5
Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: SC Methylnaltrexone (MNTX)
  • Drug: IV Methylnaltrexone (MNTX)
  • Drug: Oral Paroxetine
  • Drug: SC Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Aug 1, 2006
Actual Study Completion Date :
Aug 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Plasma Concentration of MNTX [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

  1. Plasma Concentration of Paroxetine [4 months]

    The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Progenics Pharmaceuticals Tarrytown New York United States 10591

Sponsors and Collaborators

  • Bausch Health Americas, Inc.

Investigators

  • Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01367535
Other Study ID Numbers:
  • MNTX 1108
First Posted:
Jun 7, 2011
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Naltrexone
Methylnaltrexone
Paroxetine

Study Results

No Results Posted as of Nov 27, 2019