Status:
COMPLETED
TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins.
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C
Viruses
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether TMC435 influences the activity of certain drug-degrading proteins in the human body. The drug-degrading proteins investigated in this study belong to ...
Detailed Description
This is an open-label 2-period randomized cross-over trial in 16 healthy volunteers. Eligible volunteers will be randomized to 2 groups. Volunteers in Group A will receive in Period 1 a single dose of...
Eligibility Criteria
Inclusion
- Volunteer is a non-smoker for at least 3 months prior to screening
- Healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis carried out at screening
- Normal weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
Exclusion
- No volunteers who carry certain forms of the CYP2D6, CYP2C9 and CYP2C19 genes, which cause a weak activity of these drug-degrading proteins. These forms are: genotype \*3, \*4, \*5, \*6 for CYP2D6, \*2, \*3 for CYP2C9 or \*2, \*3, \*4, \*8 for CYP2C19
- No Hepatitis A, B, or C infection at screening
- No history and/or clinical signs and symptoms of hereditary or acquired coagulation disorders
- No positive Human Immunodeficiency Virus (HIV) 1 or 2 test
- No positive pregnancy test or breast-feeding at screening
- No subjects not using adequate birth control methods.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00866853
Start Date
March 1 2009
End Date
July 1 2009
Last Update
April 28 2010
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