NCT04551261

GLS4/RTV and TAF Drug-drug Interaction

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	GLS4	It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
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.
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.

Timeline

• Start date: 2021-01-10
• Primary completion: 2021-03-12
• Completion: 2021-03-12
• First posted: 2020-09-16
• Last updated: 2022-05-26

Locations

1 site across 1 country: China