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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

June 2, 2011
July 18, 2011
April 2002
July 2002   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01367587 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone
Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers

This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
Drug: IV Methylnaltrexone
Experimental: Arm 1
Intervention: Drug: IV Methylnaltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2002
July 2002   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01367587
MNTX 253
No
Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
Not Provided
Study Director: Tage Ramakrishna, MD Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP