Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China

Recruitment & Eligibility

Inclusion Criteria

Willing and able to provide written informed consent
Healthy men or women based on history, physical examination, laboratory examination and ECG.
Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin
All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin
Others as specified in the detailed protocol

Exclusion Criteria

Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors.
Has a history of drug or food allergy.
Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
Pregnant, lactating or menstrual period and unwilling to reliable contraception period women of childbearing age.
Female partners have fertility and reliable contraceptive measures of men.

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days;
PK Group (Danoprevir,Ritonavir)	Ritonavir	Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13;
PK Group (Danoprevir,Ritonavir)	Danoprevir	Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14;100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13;
Placebo Group	Ritonavir	ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13 for 14 days;

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	40 days
Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state	Up to 16 days
Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max)	Up to 16 days

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility