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

Sponsor
Ascletis Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03019991
Collaborator
(none)
18
Enrollment
2
Arms
1
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.

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:
A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: PK Group (Danoprevir,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;

Drug: Danoprevir
Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
Other Names:
  • ASC08

    • Drug: Ritonavir
    Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
    Other Names:
  • RTV

    		•
    Placebo Comparator: Placebo Group

    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;

    Drug: Ritonavir
    Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
    Other Names:
  • RTV

    • Drug: Placebo
    ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13

    Outcome Measures

    Primary Outcome Measures

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

    2. Pharmacokinetics: Maximum plasma concentration at steady-state (Css,max) [Up to 16 days]

    3. Pharmacokinetics: Total area under the concentration-time curve form time 0 to 12 hours post-dose at steady-state [Up to 16 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

    • 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.

    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:
    NCT03019991
    Other Study ID Numbers:
    • ASC08201501
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Jan 13, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ascletis Pharmaceuticals Co., Ltd.
    pharmacokinetics,Danoprevir
    Additional relevant MeSH terms:
    Ritonavir

    Study Results

    No Results Posted as of Jan 13, 2017