GLS4/RTV and TAF Drug-drug Interaction

Phase 1

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: GLS4; Drug: RTV; Drug: TAF

• Registration Number: NCT04551261
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-16
• Study Start: 2021-01-10
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Status Verified: 2021-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A	GLS4	Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
Part A	RTV	Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
Part A	TAF	Subjects will receive GLS4 and RTV on Day 1, TAF on Day 5-14, GLS4 and RTV and TAF on Day15.
Part B	TAF	Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
Part B	GLS4	Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.
Part B	RTV	Subjects will receive TAF on Day 1, GLS4 and RTV on Day 5-14, GLS4 and RTV and TAF on Day15.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China