TMC435350-TiDP16-C101 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of Increasing Oral Doses of TMC435350 After Single and Repeated Dosing

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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 session in 6 HCV genotype1 infected patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Simeprevir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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