Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

November 26, 2019 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Tarrytown, New York, United States, 10591
        • Progenics Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: IV Methylnaltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration of IV MNTX
Time Frame: 3 weeks
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks
Clearance of IV MNTX
Time Frame: 3 weeks
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
3 weeks
Half-life of IV MNTX
Time Frame: 3 weeks
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
3 weeks
Volume of Distribution of IV MNTX
Time Frame: 3 weeks
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
3 weeks
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.
3 weeks
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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

July 1, 2002

Study Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 3, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNTX 253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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