Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: IV Methylnaltrexone

• Registration Number: NCT01367587
• Lead Sponsor: Bausch Health Americas, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2002-07
• Study Completion: 2002-07
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	IV Methylnaltrexone	-

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Clearance of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Half-life of IV MNTX	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Volume of Distribution of IV MNTX	3 weeks	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	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Percentage of IV MNTX Excreted in Urine	3 weeks	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Trial Locations

Locations (1)

Progenics Pharmaceuticals, Inc.; 🇺🇸 Tarrytown, New York, United States