Overview

A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the single-dose pharmacokinetics of the immunosuppressants cyclosporine and tacrolimus in healthy participants. Cyclosporine and tacrolimus are immunosuppressants used to prevent transplant rejection and may therefore potentially be coadministered with TMC435 in patients infected with hepatitis C virus that undergo liver transplantation. We will also explore the short-term safety and tolerability following coadministration of TMC435 at steady-state and (1) cyclosporine or (2) tacrolimus after single dosing in healthy participants. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Treatments:
Cyclosporine
Cyclosporins
Immunosuppressive Agents
Simeprevir
Tacrolimus
Criteria
Inclusion Criteria:

- Women must be postmenopausal for at least 2 years, OR be surgically sterile, OR be not
heterosexually active for the duration of the study or have a vasectomized partner OR
if of childbearing potential and heterosexually active, be practicing a highly
effective method of birth control before entry, and agree to continue to use the same
method of contraception throughout the study and for at least 30 days after the last
administration of study drug(s).

Exclusion Criteria:

- A positive Human Immunodeficiency Virus (HIV)-1 or HIV-2 test at screening;

- A positive Hepatitis A, B and C test at screening