Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone
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ClinicalTrials.gov Identifier: NCT01367587 |
Recruitment Status
:
Completed
First Posted
: June 7, 2011
Last Update Posted
: July 19, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteers | Drug: IV Methylnaltrexone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2002 |
Actual Primary Completion Date : | July 2002 |
Actual Study Completion Date : | July 2002 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 | Drug: IV Methylnaltrexone |
- Peak Plasma Concentration of IV MNTX [ Time Frame: 3 weeks ]To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
- 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.
- Clearance of IV MNTX [ Time Frame: 3 weeks ]To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
- Half-life of IV MNTX [ Time Frame: 3 weeks ]To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
- Volume of Distribution of IV MNTX [ Time Frame: 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 [ Time Frame: 3 weeks ]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 ]To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367587
United States, New York | |
Progenics Pharmaceuticals, Inc. | |
Tarrytown, New York, United States, 10591 |
Study Director: | Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. |
Responsible Party: | Tage Ramakrishna, MD, Progenics Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT01367587 History of Changes |
Other Study ID Numbers: |
MNTX 253 |
First Posted: | June 7, 2011 Key Record Dates |
Last Update Posted: | July 19, 2011 |
Last Verified: | July 2011 |
Additional relevant MeSH terms:
Methylnaltrexone Naltrexone Narcotic Antagonists |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |