Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367587
• Other study ID #: MNTX 253
• Status: Completed
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: July 2002

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• IV Methylnaltrexone

Locations

Country	Name	City	State
United States	Progenics Pharmaceuticals, Inc.	Tarrytown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration of IV MNTX	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks
Secondary	Time to Maximum Plasma Concentration of IV MNTX	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks
Secondary	Clearance of IV MNTX	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks
Secondary	Half-life of IV MNTX	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks
Secondary	Volume of Distribution of IV MNTX	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks
Secondary	Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks
Secondary	Percentage of IV MNTX Excreted in Urine	To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.	3 weeks