A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: telaprevir
* Drug: telaprevir
* Drug: cyclosporine
* Drug: cyclosporine
* Drug: tacrolimus
* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female (non-childbearing potential) or male subjects between 18 and 60 years of age (inclusive) Body mass index (BMI) from 18 to 30 kg/m2 (inclusive) at the Screening Visit and Day 1, and weigh more than 50 kg at Screening. Exclusion Criteria: History of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. Participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months or 5 half-lives (whichever is longer) before the Screening Visit. Positive result for any of the following infectious disease tests: hepatitis B antigen, hepatitis C virus antibody, human immunodeficiency virus 1 antibody, or human immunodeficiency virus 2 antibody.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>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. | Drug: telaprevir<br>* Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2<br>Drug: cyclosporine<br>* Solution, Oral, 100mg, Day 1 of Period 1<br>Drug: cyclosporine<br>* Solution, Oral, 10mg, Day 1 and Day 8 of Period 2<br>|
| Experimental: Part B<br>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. | Drug: telaprevir<br>* Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2<br>Drug: tacrolimus<br>* Capsule, Oral, 2mg, Day 1 of Period 1<br>Drug: tacrolimus<br>* Capsule, Oral, 0.5mg, Day 8 of Period 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VX-950