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| Name | Class |
|---|---|
| Tibotec Pharmaceutical Limited | INDUSTRY |
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The purpose of this study is to evaluate the effect that telaprevir has on the pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Part A will be administered in two periods, separated by a washout. In Period 1, subjects will receive cyclosporine alone. In Period 2, subjects will receive cyclosporine in combination with telaprevir. |
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| Part B | Experimental | Part B will be administered in two periods, separated by a washout. In Period 1, subjects will receive tacrolimus alone. In Period 2, subjects will receive tacrolimus in combination with telaprevir. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telaprevir | Drug | Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2) | 33 days | |
| Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax) | 33 days for Part A; 44 days for Part B | |
| Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2) | 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations | 33 days for Part A; 44 days for Part B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dallas | Texas | United States |
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| telaprevir |
| Drug |
Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2 |
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| cyclosporine | Drug | Solution, Oral, 100mg, Day 1 of Period 1 |
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| cyclosporine | Drug | Solution, Oral, 10mg, Day 1 and Day 8 of Period 2 |
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| tacrolimus | Drug | Capsule, Oral, 2mg, Day 1 of Period 1 |
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| tacrolimus | Drug | Capsule, Oral, 0.5mg, Day 8 of Period 2 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C486464 | telaprevir |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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