HCV
Conditions
Interventions
1:Seraprevir (GP205) 200mg(BID)
2:Seraprevir (GP205) 400mg(QD)
3:Seraprevir (GP205)400mg(BID)
4:Seraprevir (GP205) 600mg(BID)
5:Seraprevir (GP205) 600mg(QD)
Sponsors
Jilin university first hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed Consent form; (1) subjects agree with informed consent before screening, and to sign informed consent form voluntely, including accpeting screening procedure for diagonose; (2) Subject could have good communication with investigators and comply with protocol to conduct the study; 2. Target population: subjects with Chronic hepatitis C virus infection, with criteria below: (1) nave subjects with hepatitis C genotype 1 or 2; (2) no treatment history of market product or clinical research of DAA for hepatitis C, such as BoceprevirTelaprevirSimeprevirSofosbuvirDaclatasvirAsunaprevir, interferon, and ribavirin; (3) No treatment of Chinese medicine of anti-virus (label indicated for anti-virus), immune modulators, thymosin, or other immune stimulating factors for anti-virus therapy; (4) HCV RNA level higher than 1'105 IU/mL(Roche COBAS Taqman)in screening; (5) clinical diagose of chronic hepatitis C; (6) Serum ALT should be lower than 10*ULN/l; (7) FibroScan<17.5 kPa; 3. General Condition (1) aged between 18-65, number of male and female subjects is almost the same; (2) enrollment criteria for female subjects; No fertility(such as hysterectomy, oophorectomy or medical evidence of Ovarian failure); Fertility (age lower than 50 with menostasis is recognized as fertility) pregnancy test in screening, baseline should be negative, and agree to adopt contraception from screening to six months after last dose, such as avoid sex, condum, intrauterine device, etc; (3) male sujects should agree to adopt contraception with Female partners from screening to six months after last dose (except Surgical sterilization), such as avoid sex, condum, intrauterine device, etc; (4) Body mass index is between 18-28 kg/ m2.
Exclusion criteria
Exclusion criteria: 1. gender and birth: (1) use of Long-term estrogen, progestational hormone or Preparetions piece within 4-week before first dose; (2) female with Fertility without appropriate contraception within 2-week before first dose; (3) preganancy, suckling period, or plan for preganacy within 6-month after last dose; (4) any positive results from screening to first dose; 2. physical exam and lab test: (1) any abnormal of platelet count, WBC count, hemoglobin, albumin with clinical significant; (2) Grade B or C of Child-Pugh; (3) ECG result in screening, male QTc>470 msfemale QTc>480 ms; (4) CLcr <=60mL/minmaleCLcr (mL/min) =(140 -age)*body weight(kg)*88.4/(72*CREA (umol/L))femaleCLcr (mL/min) = (140-age)*body weight(kg)*88.4*0.85/(72*CREA (umol/L)); (5) any other abnormal lab results with clinical significant diagonized by investigator which is unrelated to HCV infection; 3. forbidden therapy and/or medicine: (1) treated by Inhibiting gastric acid drugs within 4-week before first dose, such as Cimetidine, ranitidine, famotidine, ranitidine, nizatidine and roxatidine; proton pump inhibitors omeprazole, lansoprazole, ray Bella, pantoprazole and esomeprazole; cholinergic receptor blocking drugs atropine and pirenzepine; (2) treated by anti-acid drugs within 4-week before first dose, such as sodium bicarbonate, magnesium hydroxide, aluminum hydroxide, calcium carbonate, silicate magnesium; (3) treated by drugs with Inhibiting or inducing liver function within 4-week before first dose, refer to appendix; (4) treated by drugs with Promoting gastric dynamics drugs within 4-week before first dose, such as methoxy metoclopramide, domperidone, cisapride and Mosapride; (5) long term therepy of drugs which introduce immune inhibition, or in high risk of kidney toxicity, and affecting liver efflux, such as immunosuppression, or high risk for nephrotoxicity or hepatotoxicity, or affect the hepatic metabolism of drugs, such as immune suppression of systemic administration of drugs and prednisone, mycophenolate mofetil, cyclosporine and anti metabolism drugs (such as azathioprine); renal toxicity amphotericin B, aminoglycoside, foscarnet; drug hepatotoxicity - isoniazid; 4. medical history and surgical history: (1) clinical evidence of hepatic decompensation, including but not limited to: hepatic encephalopathy, liver cancer, variceal bleeding, splenomegaly, ascites; (2) any non HCV liver disease with them, including but not limited to redness of the skin pigmentation disease, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non alcoholic fatty hepatitis; (3) other can cause elevated ALT disease judged by researchers; (4) With HBV, HIV or (5) positive syphilis detection; (6) with a history of implement qualitative sex heart disease, history of heart failure, myocardial infarction history, history of angina pectoris, cannot explain the arrhythmia history, torsion ventricular velocity history, ventricular tachycardia velocity history, QT prolongation syndrome or a history of long QT syndrome symptoms and family history, genetic evidence or near relatives at a young age due to cardiac causes sudden death). (7) of patients with chronic obstructive pulmonary disease; (8) the clinical significance of hemoglobin disease (such as sickle cell disease, thalassemia); (9) suffering from gastrointestinal peristalsis, may interfere with PH or study drug absorption of gastrointestinal diseases or diseas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerability;PK;PD; | — |
Countries
China
Contacts
Public ContactDingYanhua
Outcome results
None listed