Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
| |
| Arm 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC Methylnaltrexone (MNTX) | Drug |
| ||
| IV Methylnaltrexone (MNTX) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of MNTX | The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Paroxetine | The objective of this study is to assess the effect of SC or IV doses of MNTX on CYP450 2D6 activity. | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tage Ramakrishna, MD | Progenics Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals | Tarrytown | New York | 10591 | United States |
Not provided
| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Oral Paroxetine | Drug |
|
| SC Placebo | Drug |
|