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

Sunshine Lake Pharma Co., Ltd.1 site in 1 country28 target enrollmentJanuary 10, 2021

ConditionsChronic Hepatitis B

InterventionsGLS4 RTV TAF

DrugsGLS4 RTV TAF

Overview

Phase: Phase 1
Intervention: GLS4
Conditions: Chronic Hepatitis B
Sponsor: Sunshine Lake Pharma Co., Ltd.
Enrollment: 28
Locations: 1
Primary Endpoint: Adverse event
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 10, 2021

End Date

March 12, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sunshine Lake Pharma Co., Ltd.

Responsible Party

Sponsor

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;