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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038167
First Posted: December 23, 2009
Last Update Posted: April 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Vertex Pharmaceuticals Incorporated
  Purpose
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.

Condition Intervention Phase
Hepatitis C Drug: telaprevir Drug: cyclosporine Drug: tacrolimus Phase 1

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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2) [ Time Frame: 33 days ]
  • 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 ]
  • Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2) [ Time Frame: 44 days ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A
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
Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2
Drug: cyclosporine
Solution, Oral, 100mg, Day 1 of Period 1
Drug: cyclosporine
Solution, Oral, 10mg, Day 1 and Day 8 of Period 2
Experimental: Part B
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
Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2
Drug: tacrolimus
Capsule, Oral, 2mg, Day 1 of Period 1
Drug: tacrolimus
Capsule, Oral, 0.5mg, Day 8 of Period 2

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038167


Locations
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01038167     History of Changes
Other Study ID Numbers: VX09-950-021
First Submitted: December 18, 2009
First Posted: December 23, 2009
Last Update Posted: April 8, 2010
Last Verified: April 2010

Keywords provided by Vertex Pharmaceuticals Incorporated:
VX-950

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Tacrolimus
Cyclosporins
Cyclosporine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents