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Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

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ClinicalTrials.gov Identifier: NCT01367587
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

Study Description
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Brief Summary:
This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: IV Methylnaltrexone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers
Study Start Date : April 2002
Actual Primary Completion Date : July 2002
Actual Study Completion Date : July 2002

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: IV Methylnaltrexone


Outcome Measures
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Primary Outcome Measures :
  1. Peak Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.


Secondary Outcome Measures :
  1. Time to Maximum Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  2. Clearance of IV MNTX [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  3. Half-life of IV MNTX [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  4. Volume of Distribution of IV MNTX [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  5. Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  6. Percentage of IV MNTX Excreted in Urine [ Time Frame: 3 weeks ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Must be male or non-pregnant female volunteers
  2. Must be 18 to 65 yrs of age
  3. Must have no significant active disease states

Exclusion Criteria:

  1. History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric)
  2. Illicit drug users
  3. Subjects who received an experimental new drug in the past 30 days
  4. Subjects with any laboratory findings outside normal limits
Contacts and Locations
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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): NCT01367587


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01367587     History of Changes
Other Study ID Numbers: MNTX 253
First Posted: June 7, 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