Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone

This study has been completed.

Sponsor:

Information provided by:

Valeant Pharmaceuticals International, Inc.

ClinicalTrials.gov Identifier:

NCT01367587

First received: June 2, 2011

Last updated: July 18, 2011

Last verified: July 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Healthy Volunteers	Drug: IV Methylnaltrexone	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers

Resource links provided by NLM:

Drug Information available for: Methylnaltrexone

U.S. FDA Resources

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:

Peak Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

Secondary Outcome Measures:

Time to Maximum Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Clearance of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Half-life of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Volume of Distribution of IV MNTX [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
Percentage of IV MNTX Excreted in Urine [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.


Enrollment:	12
Study Start Date:	April 2002
Study Completion Date:	July 2002
Primary Completion Date:	July 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: IV Methylnaltrexone

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367587

Locations


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

Sponsors and Collaborators

Valeant Pharmaceuticals International, Inc.

Investigators


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

More Information


Responsible Party:	Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01367587 History of Changes
Other Study ID Numbers:	MNTX 253
Study First Received:	June 2, 2011
Last Updated:	July 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Methylnaltrexone Naltrexone Narcotic Antagonists	Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2016

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