Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China
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ClinicalTrials.gov Identifier: NCT03020134 |
Recruitment Status :
Completed
First Posted : January 13, 2017
Last Update Posted : June 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Ravidasvir Drug: Danoprevir Drug: Ritonavir Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of Pharmacokinetics and Safety of Ravidasvir in Combination With Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Participants |
Actual Study Start Date : | July 15, 2016 |
Actual Primary Completion Date : | August 22, 2016 |
Actual Study Completion Date : | August 22, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
Ravidasvir + Danoprevir/ Ritonavir
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Drug: Ravidasvir
Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
Other Name: ASC16(RDV) Drug: Danoprevir Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
Other Name: ASC08 (DNV) Drug: Ritonavir Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
Other Name: RTV |
Placebo Comparator: Placebo Group
Placebo
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Drug: Placebo
Placebo |
- Safety: Incidence of adverse events [ Time Frame: 40 days ]
- Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) [ Time Frame: Up to 24 weeks ]
- Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state [ Time Frame: Up to 24 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020134
Study Director: | Huoling Tang, PhD | Ascletis Pharmaceuticals Co., Ltd. |
Responsible Party: | Ascletis Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03020134 |
Other Study ID Numbers: |
ASC162002 |
First Posted: | January 13, 2017 Key Record Dates |
Last Update Posted: | June 29, 2018 |
Last Verified: | November 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
pharmacokinetics Danoprevir/r Ravidasvir |
Ritonavir HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |