Back to resultsGLS4/RTV and TAF Drug-drug Interaction
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GLS4
RTV
TAF
Sponsored by
About this trial
This is an interventional other trial for Chronic Hepatitis B
Eligibility Criteria
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;
Sites / Locations
- The First Hospital of Jilin University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A
Part B
Arm Description
Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
Outcomes
Primary Outcome Measures
Cmax
maximum observed plasma concentration
AUC
area under the plasma concentration-time curve (AUC)
Adverse event
To assess the safety and tolerability of therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT04551261
First Posted
September 8, 2020
Last Updated
May 20, 2022
Sponsor
Sunshine Lake Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04551261
Brief Title
GLS4/RTV and TAF Drug-drug Interaction
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A
Arm Type
Experimental
Arm Description
Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
Arm Title
Part B
Arm Type
Experimental
Arm Description
Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
Intervention Type
Drug
Intervention Name(s)
GLS4
Intervention Description
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
Intervention Type
Drug
Intervention Name(s)
RTV
Other Intervention Name(s)
ritonavir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TAF
Other Intervention Name(s)
tenofovir alafenamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cmax
Description
maximum observed plasma concentration
Time Frame
predose to 96 hour after dosing
Title
AUC
Description
area under the plasma concentration-time curve (AUC)
Time Frame
predose to 96 hour after dosing
Title
Adverse event
Description
To assess the safety and tolerability of therapy.
Time Frame
Baseline to day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Facility Information:
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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GLS4/RTV and TAF Drug-drug Interaction
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