GLS4/RTV and TAF Drug-drug Interaction

NCT ID: NCT04551261

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-10
• Study Completion Date: 2021-03-12

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Part A

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

Group Type: EXPERIMENTAL

GLS4

Intervention Type: DRUG

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

RTV

Intervention Type: DRUG

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.

TAF

Intervention Type: DRUG

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.

Part B

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

Group Type: EXPERIMENTAL

GLS4

Intervention Type: DRUG

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

RTV

Intervention Type: DRUG

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.

TAF

Intervention Type: DRUG

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.

Interventions

GLS4

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

Intervention Type: DRUG

RTV

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ritonavir; tenofovir alafenamide

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

PCD-DGLS4-20-001

Identifier Type: -

Identifier Source: org_study_id