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

Sponsor
Ascletis Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03020134
Collaborator
(none)
18
Enrollment
2
Arms
1.2
Actual Duration (Months)

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jul 15, 2016
Actual Primary Completion Date :
Aug 22, 2016
Actual Study Completion Date :
Aug 22, 2016

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • RTV

    		•
    Placebo Comparator: Placebo Group

    Placebo

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Safety: Incidence of adverse events [40 days]

    Secondary Outcome Measures

    1. Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) [Up to 24 weeks]

    2. Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state [Up to 24 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ascletis Pharmaceuticals Co., Ltd.

    Investigators

    • Study Director: Huoling Tang, PhD, Ascletis Pharmaceuticals Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ascletis Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03020134
    Other Study ID Numbers:
    • ASC162002
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Jun 29, 2018
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ascletis Pharmaceuticals Co., Ltd.
    pharmacokinetics
    Danoprevir/r
    Ravidasvir
    Additional relevant MeSH terms:
    Ritonavir

    Study Results

    No Results Posted as of Jun 29, 2018