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The primary objective of this study is to evaluate the pharmacokinetics of various TRV734 formulations in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation A | Experimental |
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| Formulation B | Experimental |
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| Formulation C | Experimental |
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| Formulation D | Experimental |
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| Formulation E | Experimental |
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| Formulation F | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRV734 | Drug | Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the maximum observed plasma concentration (Cmax) | 9-days | |
| Evaluate the time at which the maximum plasma concentration was observed (tmax) | 9-days | |
| Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t) | 9-days | |
| Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf) | 9-days | |
| Evaluate the apparent elimination half-life (t1/2) | 9-days | |
| Evaluate the apparent clearance (CL/F) | 9-days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as measured by adverse events | 9-days | |
| Safety and tolerability as measured by clinical observations | 9-days | |
| Safety and tolerability as measured by 12-lead ECGs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | 78209 | United States |
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| 9-days |
| Safety and tolerability as measured by cardiac telemetry monitoring | 9-days |
| Safety and tolerability as measured by vital signs (BP, HR, RR and oral temperature) | 9-days |
| Safety and tolerability as measured by oxygen saturation | 9-days |
| Safety and tolerability as measured by safety laboratory tests | 9-days |