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This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Oral methylnaltrexone |
|
| Arm 2 | Experimental | Oral methylnaltrexone |
|
| Arm 3 | Experimental | Oral methylnaltrexone |
|
| Arm 4 | Placebo Comparator | Oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral methylnaltrexone | Drug |
| ||
| Oral placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days |
| Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of 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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| Drug |
|
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers |
| 7 days |
| Half-life of oral doses of MNTX | To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers | 7 days |