Status:
COMPLETED
TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir
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 on the steady-state pharmacokinetics of efavirenz or raltegravir , and vice versa. Steady state is a ter...
Detailed Description
TMC435 is being investigated for treatment of chronic hepatitis C virus (HCV) infection, in combination with Peg-IFN (pegylated interferon) and RBV (ribavirin). About 30% of all HIV infected patients ...
Eligibility Criteria
Inclusion
- No-smoker for at least 3 months
- Body Mass Index of 18.0 to 30.0 kg/m2
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
Exclusion
- Infection with Hepatitis A, B or C Virus
- Infection with the Human Immunodeficiency Virus (HIV)
- History of, or any current medical condition which could impact the safety of the participant in the study
- Having previously participated in a multiple-dose trial with TMC435
- Having previously participated in more than 3 single-dose trials with TMC435.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01241773
Start Date
October 1 2010
End Date
April 1 2011
Last Update
November 8 2012
Active Locations (1)
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1
Berlin, Germany