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OpenTrials
Completed

NCT Number: NCT01367587

Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Progenics Pharmaceuticals, Inc.

Tarrytown, New York, 10591, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric)
  • Illicit drug users
  • Subjects who received an experimental new drug in the past 30 days
  • Subjects with any laboratory findings outside normal limits

Treatment and study plan

IV Methylnaltrexone

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study title

Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
Jun 7, 2011
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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