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Tolerance and Pharmacokinetics Study of MNTX Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01366339
First Posted: June 6, 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 6, 2011
July 19, 2011
October 2003
December 2003   (Final data collection date for primary outcome measure)
Peak Plasma Concentration (Cmax) of oral doses of MNTX [ Time Frame: 7 days ]
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Same as current
Complete list of historical versions of study NCT01366339 on ClinicalTrials.gov Archive Site
  • Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX [ Time Frame: 7 days ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
  • Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX [ Time Frame: 7 days ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
  • Half-life of oral doses of MNTX [ Time Frame: 7 days ]
    To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
Same as current
Not Provided
Not Provided
 
Tolerance and Pharmacokinetics Study of MNTX Tablets
A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Normal Healthy Volunteers
  • Drug: Oral methylnaltrexone
  • Drug: Oral placebo
  • Experimental: Arm 1
    Oral methylnaltrexone
    Intervention: Drug: Oral methylnaltrexone
  • Experimental: Arm 2
    Oral methylnaltrexone
    Intervention: Drug: Oral methylnaltrexone
  • Experimental: Arm 3
    Oral methylnaltrexone
    Intervention: Drug: Oral methylnaltrexone
  • Placebo Comparator: Arm 4
    Oral placebo
    Intervention: Drug: Oral placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2003
December 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Weight between 55 and 85 kg
  2. In good health with no evidence of a clinically significant chronic medical condition
  3. Non-Smokers.

Exclusion Criteria:

  1. History of asthma, allergic skin rash, significant allergy or other immunologic disorder
  2. Known or suspected hypersensitivity to opioids or opioid antagonists
  3. History or suspicion of alcohol or drug abuse.
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01366339
MNTX 1201
No
Not Provided
Not Provided
Tage Ramakrishna, MD, 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