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Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367483
First received: May 27, 2011
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Healthy Male Volunteers
 Drug: IV methylnaltrexone (MNTX)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Peak Plasma and Whole Blood Concentration (Cmax) of IV MNTX [ Time Frame: 5.5 days ] [ Designated as safety issue: No ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.


Secondary Outcome Measures:
  • Time to Maximum (Tmax) in Plasma and Whole Blood Concentration of IV MNTX [ Time Frame: 5.5 Days ] [ Designated as safety issue: No ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  • 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.

  • Half-life of IV MNTX [ Time Frame: 5.5 days ] [ Designated as safety issue: No ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  • Volume of Distribution of IV MNTX [ Time Frame: 5.5 days ] [ Designated as safety issue: No ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.

  • Urinary Clearance of IV MNTX [ Time Frame: 5.5 days ] [ Designated as safety issue: No ]
    To study the pharmacokinetics of MNTX following a single IV dose of 14C-MNTX in normal, healthy volunteers.


Estimated Enrollment: 6
Study Start Date: June 2005
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm1
MNTX active treatment
 Drug: IV methylnaltrexone (MNTX)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367483

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

No publications provided

Responsible Party: Tage Ramakrishna, MD, Progenics Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01367483     History of Changes
Other Study ID Numbers: MNTX 102
Study First Received: May 27, 2011
Last Updated: July 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Methylnaltrexone
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013