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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
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Ravidasvir Drug: Danoprevir Drug: Ritonavir Drug: Placebo Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arms and Interventions
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Arm Intervention/treatment
Experimental: PKGroup(Ravidasvir/Danoprevir/Ritonavir)
Ravidasvir + Danoprevir/ Ritonavir
 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
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 40 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) [ Time Frame: Up to 24 weeks ]
  2. 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 ]

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

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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Huoling Tang, PhD Ascletis Pharmaceuticals Co., Ltd.
More Information
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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
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
pharmacokinetics
Danoprevir/r
Ravidasvir
Additional relevant MeSH terms:
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Ritonavir
HIV 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