Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01367587
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: IV Methylnaltrexone	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers
• Study Start Date: Apr 1, 2002
• Actual Primary Completion Date: Jul 1, 2002
• Actual Study Completion Date: Jul 1, 2002

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Time to Maximum Plasma Concentration of IV MNTX [3 weeks]

   To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

2. Clearance of IV MNTX [3 weeks]

   To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

3. Half-life of IV MNTX [3 weeks]

   To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

4. Volume of Distribution of IV MNTX [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 [3 weeks]

   To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

6. Percentage of IV MNTX Excreted in Urine [3 weeks]

   To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Progenics Pharmaceuticals, Inc.	Tarrytown	New York	United States	10591

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01367587
• Other Study ID Numbers: MNTX 253
• First Posted: Jun 7, 2011
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Methylnaltrexone

Study Results

No Results Posted as of Nov 27, 2019