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Tolerance and Pharmacokinetics Study of MNTX Tablets

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ClinicalTrials.gov Identifier: NCT01366339
Recruitment Status : Completed
First Posted : June 6, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Normal Healthy Volunteers Drug: Oral methylnaltrexone Drug: Oral placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
Study Start Date : October 2003
Primary Completion Date : December 2003
Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Oral methylnaltrexone
Drug: Oral methylnaltrexone
Experimental: Arm 2
Oral methylnaltrexone
Drug: Oral methylnaltrexone
Experimental: Arm 3
Oral methylnaltrexone
Drug: Oral methylnaltrexone
Placebo Comparator: Arm 4
Oral placebo
Drug: Oral placebo


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366339


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

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01366339     History of Changes
Other Study ID Numbers: MNTX 1201
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents