GLS4/RTV and TAF Drug-drug Interaction

NCT04551261 | Completed Phase 1

• 1 other identifier: PCD-DGLS4-20-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Cmax

  maximum observed plasma concentration

  predose to 96 hour after dosing

• AUC

  area under the plasma concentration-time curve (AUC)

  predose to 96 hour after dosing

• Adverse event

  To assess the safety and tolerability of therapy.

  Baseline to day 22

Study Arms (2)

Part A

EXPERIMENTAL

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

Drug: GLS4; Drug: RTV; Drug: TAF

Part B

EXPERIMENTAL

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

Drug: GLS4; Drug: RTV; Drug: TAF

Interventions

GLS4 DRUG

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

Part A; Part B

RTV 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.

Also known as: ritonavir

Part A; Part B

TAF 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.

Also known as: tenofovir alafenamide

Part A; Part B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Ritonavir; tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: January 10, 2021
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: May 26, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)