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

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ClinicalTrials.gov Identifier: NCT01038167
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : April 8, 2010
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE December 18, 2009
First Posted Date  ICMJE December 23, 2009
Last Update Posted Date April 8, 2010
Study Start Date  ICMJE January 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01038167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults
Official Title  ICMJE An Open-Label Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: telaprevir
    Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2
  • Drug: telaprevir
    Tablet, Oral, 750mg, every 8 hours, Day 1-13 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
  • Drug: tacrolimus
    Capsule, Oral, 2mg, Day 1 of Period 1
  • Drug: tacrolimus
    Capsule, Oral, 0.5mg, Day 8 of Period 2
Study Arms
  • 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.
    Interventions:
    • Drug: telaprevir
    • Drug: cyclosporine
    • Drug: cyclosporine
  • 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.
    Interventions:
    • Drug: telaprevir
    • Drug: tacrolimus
    • Drug: tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 18, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01038167
Other Study ID Numbers  ICMJE VX09-950-021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Collaborators  ICMJE Tibotec Pharmaceutical Limited
Investigators  ICMJE
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP