Status:
COMPLETED
A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Detailed Description
TMC435 is a protease inhibitor (PI) and is being investigated for treatment of chronic hepatitis C virus (HCV) infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). This i...
Eligibility Criteria
Inclusion
- 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
- A positive Human Immunodeficiency Virus (HIV)-1 or HIV-2 test at screening;
- A positive Hepatitis A, B and C test at screening
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01479881
Start Date
October 1 2011
End Date
December 1 2011
Last Update
November 1 2012
Active Locations (1)
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1
Merksem, Belgium