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Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01367587
First received: June 2, 2011
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.


Condition Intervention Phase
Healthy Volunteers
 Drug: IV Methylnaltrexone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Peak Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.


Secondary Outcome Measures:
  • Time to Maximum Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  • Clearance of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  • Half-life of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  • Volume of Distribution of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  • Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

  • Percentage of IV MNTX Excreted in Urine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Enrollment: 12
Study Start Date: April 2002
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: IV Methylnaltrexone

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367587

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, Inc.
ClinicalTrials.gov Identifier: NCT01367587     History of Changes
Other Study ID Numbers: MNTX 253
Study First Received: June 2, 2011
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 03, 2015