Clincosm LogoSign in Get a demo

GLS4/RTV and TAF Drug-drug Interaction

Sponsor
Sunshine Lake Pharma Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04551261
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
14
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase I, Single-center, Open Label Clinical Study, to Evaluate the Pharmacokinetic Character of GLS4 Combined With RTV or TAF Alone or GLS4 and RTV and TAF Combination Administration in Healthy Subjects
Actual Study Start Date :
Jan 10, 2021
Actual Primary Completion Date :
Mar 12, 2021
Actual Study Completion Date :
Mar 12, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part A

Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.

Drug: GLS4
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.

Drug: RTV
It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection; It is a CYP3A inhibitor combined with other drug to increase the exposure in human.
Other Names:
  • ritonavir

    • Drug: TAF
    It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
    Other Names:
  • tenofovir alafenamide

    		•
    Experimental: Part B

    Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.

    Drug: GLS4
    It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.

    Drug: RTV
    It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection; It is a CYP3A inhibitor combined with other drug to increase the exposure in human.
    Other Names:
  • ritonavir

    • Drug: TAF
    It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
    Other Names:
  • tenofovir alafenamide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax [predose to 96 hour after dosing]

      maximum observed plasma concentration

    2. AUC [predose to 96 hour after dosing]

      area under the plasma concentration-time curve (AUC)

    3. Adverse event [Baseline to day 22]

      To assess the safety and tolerability of therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Males or females, of any race, between 18 and 50 years of age, inclusive, at Screening;

    • Body mass index between 18.0 and 28.0 kg/m2, inclusive, at Screening;

    • Females of childbearing potential and male subjects will agree to use contraception from screening to the 6 months after the last administration.

    Exclusion Criteria:

    • In the 12 months prior to screening, observing clinical significance of the following diseases, including but not limited to, gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardio-cerebrovascular diseases;

    • Allergic constitution (multiple drug and food allergies);

    • A history of alcoholism;

    • Take any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days of screening;

    • Any drug that changes the liver enzyme activity, such as barbiturates and Rifampicin, was taken within 30 days before screening;

    • P-GP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 or MRP4 inhibitors or inducers, such as azithromycin, pantoprazole or St. John's herb, etc., was taken within 30 days before screening;

    • Female subjects are lactating or have positive blood pregnancy results during the screening period;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Hospital of Jilin University Changchun Jilin China 130000

    Sponsors and Collaborators

    • Sunshine Lake Pharma Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunshine Lake Pharma Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04551261
    Other Study ID Numbers:
    • PCD-DGLS4-20-001
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis B, Chronic
    Ritonavir
    Tenofovir

    Study Results

    No Results Posted as of May 26, 2022