Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants

Official Title
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Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Ravidasvir
* Drug: Danoprevir
* Drug: Ritonavir
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG. If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication. If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication. If female, negative pregnancy test during the screening period. Others as specified in the detailed protocol Exclusion Criteria: History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor. Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption. Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method. Others as specified in the detailed protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PKGroup(Ravidasvir/Danoprevir/Ritonavir)<br>Ravidasvir + Danoprevir/ Ritonavir | Drug: Ravidasvir<br>* Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23<br>* Other names: ASC16(RDV);Drug: Danoprevir<br>* Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23<br>* Other names: ASC08 (DNV);Drug: Ritonavir<br>* Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23<br>* Other names: RTV;|
| Placebo Comparator: Placebo Group<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) |  | Up to 24 weeks | 
| Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state |  | Up to 24 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, Danoprevir/r, Ravidasvir