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This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Methylnaltrexone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration of IV MNTX | To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration of IV MNTX | To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers. | 3 weeks |
| Clearance of IV MNTX |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals, Inc. | Tarrytown | New York | 10591 | United States |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers.
| 3 weeks |
| Half-life of IV MNTX | To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers. | 3 weeks |
| Volume of Distribution of IV MNTX | To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers. | 3 weeks |
| 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 |
| Percentage of IV MNTX Excreted in Urine | To evaluate plasma pharmacokinetics of multiple-doses of intravenous methylnaltrexone in healthy human volunteers. | 3 weeks |