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Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

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ClinicalTrials.gov Identifier: NCT01367483
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : July 19, 2011
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
This is an open-label, radiotracer study, to be conducted in healthy, normal, male volunteers. It will entail intravenous administration of a single dose of 14C-MNTX, collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be sampled as a measure of the extent of possible metabolic MNTX demethylation.

Condition or disease Intervention/treatment Phase
Healthy Male Volunteers Drug: IV methylnaltrexone (MNTX) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I, Single Dose Study of the Pharmacokinetics, Mass Balance and Disposition of Intravenously Administered 14C-Methylnaltrexone in Normal, Healthy Volunteers
Study Start Date : June 2005
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm1
MNTX active treatment
Drug: IV methylnaltrexone (MNTX)



Primary Outcome Measures :
  1. Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX [ Time Frame: 5.5 days ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.


Secondary Outcome Measures :
  1. Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX [ Time Frame: 5.5 Days ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  2. Clearance of IV MNTX [ Time Frame: 5.5 days ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  3. Half-life of IV MNTX [ Time Frame: 5.5 days ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  4. Volume of Distribution of IV MNTX [ Time Frame: 5.5 days ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  5. Urinary Clearance of IV MNTX [ Time Frame: 5.5 days ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.



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

Inclusion Criteria:

  1. Males between 18-45
  2. Subject weight between 70 and 90 kg
  3. In good physical health, with no evidence at screening of acute or chronic disease likely to affect the investigation

Exclusion Criteria:

  1. History or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, renal, or other significant chronic condition.
  2. Consumption of barbiturates or other inducers or inhibitors of CYP450 isoforms
  3. History of or predisposition to erratic or abnormal bowel function.

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): NCT01367483


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.

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01367483     History of Changes
Other Study ID Numbers: MNTX 102
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