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

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

telaprevir

cyclosporine

tacrolimus

About this trial

This is an interventional basic science trial for Hepatitis C focused on measuring VX-950

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part A

Part B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)

Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)

Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)

Secondary Outcome Measures

Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations

Full Information

NCT ID

NCT01038167

First Posted

December 18, 2009

Last Updated

April 6, 2010

Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

Tibotec Pharmaceutical Limited

1. Study Identification

Unique Protocol Identification Number

NCT01038167

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

Tibotec Pharmaceutical Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

VX-950

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A

Arm Type

Experimental

Arm Description

Arm Title

Part B

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

telaprevir

Intervention Description

Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2

Intervention Type

Drug

Intervention Name(s)

telaprevir

Intervention Description

Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2

Intervention Type

Drug

Intervention Name(s)

cyclosporine

Intervention Description

Solution, Oral, 100mg, Day 1 of Period 1

Intervention Type

Drug

Intervention Name(s)

cyclosporine

Intervention Description

Solution, Oral, 10mg, Day 1 and Day 8 of Period 2

Intervention Type

Drug

Intervention Name(s)

tacrolimus

Intervention Description

Capsule, Oral, 2mg, Day 1 of Period 1

Intervention Type

Drug

Intervention Name(s)

tacrolimus

Intervention Description

Capsule, Oral, 0.5mg, Day 8 of Period 2

Primary Outcome Measure Information:

Title

Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)

Time Frame

33 days

Title

Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)

Time Frame

33 days for Part A; 44 days for Part B

Title

Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)

Time Frame

44 days

Secondary Outcome Measure Information:

Title

Part A and Part B: Safety and tolerability as measured by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, physical examinations

Time Frame

33 days for Part A; 44 days for Part B

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Vertex Pharmaceuticals Incorporated

Official's Role

Study Director

Facility Information:

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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