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The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state. |
|
| Part B | Experimental | Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telaprevir formulation A | Drug | A single 1125-mg dose administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞) | Up to 57 days | |
| • PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast) | Up to 57 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms | Up to 57days | |
| Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas | Dallas | Texas | 75247 | United States | ||
| Wisconsin |
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| telaprevir Formulation B |
| Drug |
A single 1125-mg dose administered orally |
|
| telaprevir Formulation C | Drug | A single 1125-mg dose administered orally |
|
| telaprevir Formulation D | Drug | A single 1125-mg dose administered orally |
|
| Up to 57 Days |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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