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This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Experimental | Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL) |
|
| Severe RI | Experimental | Severe Renal Impairment subjects Tenofovir Exalidex (TXL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Exalidex (TXL) | Drug | Drug: Tenofovir Exalidex (TXL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers | Measuring Cmax : the peak plasma concentration | up to six days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the adverse events for TXL in RI subjects | review of Adverse events | up to six days post dose |
| Evaluation of safety labs for TXL in RI subjects | review of safety labs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Sullivan-Bolyai, MD, MPH | ContraVir Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Tenofovir exalidex (TXL)
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| up to six days post dose |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |