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 open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | methylnaltrexone (MNTX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylnaltrexone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of MNTX prior to and following multi-dose cimetidine regimen | To assess the potential effects of cimetidine on the pharmacokinetics of MNTX | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration (AUC) of MNTX prior to and following a multi-dose cimetidine regimen | To assess the potential effects of cimetidine on the pharmacokinetics of MNTX | 7 days |
| Half-life of MNTX prior to and following a multi-dose cimetidine regimen |
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, Inc. | Tarrytown | New York | 10591 | United States |
Not provided
| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the potential effects of cimetidine on the pharmacokinetics of MNTX |
| 7 days |
| Clearance (both total and renal)of MNTX prior to and following a multi-dose cimetidine regimen | To assess the potential effects of cimetidine on the pharmacokinetics of MNTX | 7 days |
| Volume of distribution of MNTX prior to and following a multi-dose cimetidine regimen | To assess the potential effects of cimetidine on the pharmacokinetics of MNTX | 7 days |
| Number of subject with adverse events as measured before, during, and after administration of cimetidine | To assess the potential effects of cimetidine on safety, and tolerability of MNTX | 7 days |