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

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01038167
First received: December 18, 2009
Last updated: April 6, 2010
Last verified: April 2010

December 18, 2009
April 6, 2010
January 2010
April 2010   (final data collection date for primary outcome measure)
  • Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2) [ Time Frame: 33 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2) [ Time Frame: 44 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01038167 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults
An Open-Label Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hepatitis C
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01038167
VX09-950-021
No
Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
April 2010

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