Status:
COMPLETED
TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese Volunteers
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of TMC435 in Chinese healthy volunteers. Pharmacokinetics (PK) means how the drug...
Detailed Description
TMC435 is being investigated for the treatment of chronic hepatitic C infection. The results of this study will provide dosing recommendations for the administration of TMC435 in Chinese HCV-infected ...
Eligibility Criteria
Inclusion
- Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. Body Mass Index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months.
Exclusion
- Infection with Hepatitis A, B or C virus
- infection with the Human Immunodeficiency Virus (HIV)
- Women who are pregnant or breastfeeding
- History of, or any current medical condition which could impact the safety of the participant in the study.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01224197
Start Date
October 1 2010
End Date
January 1 2011
Last Update
May 8 2014
Active Locations (1)
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1
Shatin, Hong Kong