TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin
Hepatitis C Virus
About this trial
This is an interventional treatment trial for Hepatitis C Virus focused on measuring TMC649128, HCV, TMC649128HPC1002, Hepatitis C, Hep C
Eligibility Criteria
Inclusion Criteria:
- Documented chronic (> 6 months) genotype 1a or 1b Hepatitis C virus (HCV) infection
- Treatment-naive volunteer, meaning never received (Peg)IFN, RBV or any other approved or investigational treatment for chronic HCV infection (Panels 1, 2, 3 or 4) OR volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (IFN/RBV or pegylated IFN/RBV) but has stopped this treatment at least 6 months before screening
- volunteer has never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year (Panels 1, 2 or 3)
- Volunteer with HCV plasma RNA levels of > 100,000 IU/mL at screening
- Body Mass Index of 18.0 to 35.0 kg/m2
- Healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram.
Exclusion Criteria:
- Evidence of liver cirrhosis
- Historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (Fibroscan) result of more than 14.6 kPa within 2 years prior to screening
- Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
- Evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 mL/min
- Evidence of any other cause of significant liver disease in addition to hepatitis C, this may include but is not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis
- Volunteer with diagnosed or suspected hepatocellular carcinoma
- Volunteer receiving or having received any treatment for HCV during the 6 months before screening
- Volunteer coinfected with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2, or hepatitis A or B virus infection, or clinically active tuberculosis at study screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Placebo Comparator
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009
TMC649128 panel 4 arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128 administered q12h or q24h for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1 2 and 3.
TMC649128. panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128.
placebo. panel 1: 2 participants receive placebo at a q24h regimen.
TMC649128. panel 2 arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1.
placebo. panel 2 arm 1: 2 participants receive placebo at a q12h regimen.
TMC649128. panel 2 arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1.
placebo. panel 2 arm 2: 2 participants receive placebo at a q24h regimen.
TMC649128 panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.
placebo. panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.
placebo panel 4 arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo administered q12h or q24h for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1 2 and 3.