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This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal, healthy volunteers. Study treatment entailed single doses of two different formulations of MNTX tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | MNTX tablet |
|
| Arm 2 | Experimental | MNTX tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MNTX tablet (Formulation 1) | Drug |
| ||
| MNTX tablet (Formulation 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Half-life of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days |
| Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations |
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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 determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. |
| 7 days |
| Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days |
| Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations | To determine and compare relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days |
| Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations | To determine and compare the plasma pharmacokinetics, relative bioavailability, and extent of single, oral doses of two different oral formulations of MNTX in normal healthy volunteers. | 7 days |