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Sponsored by: |
Tibotec Pharmaceuticals Limited, Ireland |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00752544 |
The purpose of this study is to evaluate the safety and tolerability of three different doses of TMC435350 compared to placebo in healthy Japanese males.
Condition | Intervention | Phase |
---|---|---|
HCV |
Drug: TMC435350 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Safety Study |
Official Title: | Phase I, Double-Blind, Randomized, Placebo-Controlled Trial to Examine the Safety, Tolerability and Plasma Pharmacokinetics of Ascending Oral Doses of TMC435350 After Single and Repeated Dosing in Healthy Japanese Male Subjects |
Enrollment: | 30 |
Study Start Date: | August 2008 |
Study Completion Date: | November 2008 |
This is a Phase I, double-blind (neither the physician or the volunteer knows the dose of the study medication), randomized (study medication assigned by chance), placebo-controlled (dose without the study medication present) trial to determine the safety, tolerability and plasma pharmacokinetics (amount of medication in the blood) of TMC435350 after single and multiple oral doses in healthy male Japanese volunteers.
100 mg, 200 mg and 400 mg doses will be given as an oral solution. Six (6) doses will be given with a 3 day follow-up between the first and second dose.
Additional follow-up will be done for 3 days after the last dose and at approximately 2 and 4 weeks after the last dose.
Ages Eligible for Study: | 20 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR015418 |
Study First Received: | September 11, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00752544 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hepatitis C TMC435350 TMC435350-TiDP16-C109 HCV TMC435350-C109 |
Hepatitis Healthy Hepatitis C |