ClinicalTrials.Veeva

Menu

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

Vertex Pharmaceuticals logo

Vertex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Hepatitis C

Treatments

Drug: telaprevir
Drug: cyclosporine
Drug: tacrolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038167
VX09-950-021

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Part A
Experimental group
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.
Treatment:
Drug: telaprevir
Drug: cyclosporine
Drug: cyclosporine
Drug: telaprevir
Part B
Experimental group
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.
Treatment:
Drug: tacrolimus
Drug: tacrolimus
Drug: telaprevir
Drug: telaprevir

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems