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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038167
• Other study ID #: VX09-950-021
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2009
• Last updated: April 6, 2010
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• telaprevir
Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2
• telaprevir
Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2
• cyclosporine
Solution, Oral, 100mg, Day 1 of Period 1
• cyclosporine
Solution, Oral, 10mg, Day 1 and Day 8 of Period 2
• tacrolimus
Capsule, Oral, 2mg, Day 1 of Period 1
• tacrolimus
Capsule, Oral, 0.5mg, Day 8 of Period 2

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Tibotec Pharmaceutical Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A only: Pharmacokinetic parameters of cyclosporine (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)		33 days	No
Primary	Part A and Part B: Pharmacokinetic parameters of telaprevir (Cmax, AUC0-8h, Cmin, tmax)		33 days for Part A; 44 days for Part B	No
Primary	Part B only: Pharmacokinetic parameters of tacrolimus (Cmax, AUC0-tlast, AUC0-inf, tmax, t1/2)		44 days	No
Secondary	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	Yes