Status:
COMPLETED
TMC435350-TiDP16-C101 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing
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 examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing ...
Detailed Description
This trial is a randomized, double blind, placebo-controlled trial to determine the safety, tolerability and pharmacokinetics of TMC435350 after single and multiple oral doses taken by healthy non-Hep...
Eligibility Criteria
Inclusion
- \- Healthy participants must be non-smokers, normal weight, normal ECG, healthy on the basis of a medical evaluation, physical examination, medical history, ECG, vital signs, and laboratory results
- HCV patients must be of normal weight, normal ECG, chronic genotype 1 HCV infection, non-responders or relapsers to previous treatment regimens and have a HCV viral load at least 50000 IU/mL plasma at screening.
Exclusion
- Patients with history of cardiac disease, HIV-1 or HIV-2 test
- Women of childbearing potential
- History or evidence of abuse of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, hepatitis A, B or C infection
- Positive urine drug test
- Any active or underlying disease
- History of drug allergy or hypersensitivity
- Participation in an investigational trial within 30 days prior to the first intake of study medication
- Recent donation of blood
- Abnormal laboratory values
- HCV patients with cardiac disease, co-infections with HIV-1, HIV-2 or liver infection other than HCV
- Women of childbearing potential
- Participants not agreeing to use a reliable birth control method until last trial visit
- Drug abuse
- Cardiovascular, hepatic or renal disease, diabetes, epilepsy, skin or psychiatric disease
- Enrolled in another clinical trial for 90 days prior to screening
- Evidence of Child Pugh B or C liver disease
- Having received a polymerase or protease inhibitor treatment during the last 6 months
- Abnormal laboratory values
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00938899
Start Date
January 1 2007
End Date
September 1 2007
Last Update
May 19 2011
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