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GLS4/RTV and TAF Drug-drug Interaction

NCT04551261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-05-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-10
Primary Completion
2021-03-12
Completion
2021-03-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04551261 on ClinicalTrials.gov