Chronic Hepatitis B
Conditions
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.
Interventions
DRUGGLS4
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
DRUGRTV
1. It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection; 2. It is a CYP3A inhibitor combined with other drug to increase the exposure in human.
DRUGTAF
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.
Sponsors
Sunshine Lake Pharma Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | predose to 96 hour after dosing | maximum observed plasma concentration |
| AUC | predose to 96 hour after dosing | area under the plasma concentration-time curve (AUC) |
| Adverse event | Baseline to day 22 | To assess the safety and tolerability of therapy. |
Countries
China
Outcome results
None listed