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OpenTrials
Completed

NCT Number: NCT04551261

GLS4/RTV and TAF Drug-drug Interaction

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

GLS4

Drug

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

RTV

Drug
  • 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.

Other names: ritonavir

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.

Other names: tenofovir alafenamide

Primary outcomes

  1. Cmax

    Time frame: predose to 96 hour after dosing

    maximum observed plasma concentration

  2. AUC

    Time frame: predose to 96 hour after dosing

    area under the plasma concentration-time curve (AUC)

  3. Adverse event

    Time frame: Baseline to day 22

    To assess the safety and tolerability of therapy.

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2020
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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