GLS4/RTV and TAF Drug-drug Interaction

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551261
• Other study ID #: PCD-DGLS4-20-001
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2021
• Est. completion date: March 12, 2021

Study information

• Verified date: May 2021
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• GLS4
It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
• RTV
It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection; It is a CYP3A inhibitor combined with other drug to increase the exposure in human.
• 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.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	maximum observed plasma concentration	predose to 96 hour after dosing
Primary	AUC	area under the plasma concentration-time curve (AUC)	predose to 96 hour after dosing
Primary	Adverse event	To assess the safety and tolerability of therapy.	Baseline to day 22