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Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants

Primary Purpose

COVID-19 Respiratory Infection

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GST-HG171/ritonavir
ritonavir
Sponsored by
Fujian Akeylink Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Respiratory Infection

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial; Ability to complete research in accordance with test plan requirements; Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration; Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old); Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 ~ 28 kg / m2 (including critical value); Physical examination, normal or abnormal vital signs have no clinical significance Exclusion Criteria: Allergies (multiple drugs and food allergies); Those who smoked more than 5 cigarettes per day in the 3 months before the trial; Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); Blood donation or massive blood loss (> 400 mL) within three months before screening; Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including a history of frequent nausea or vomiting caused by any cause; Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug; Have Intended to take any drug that changes the activity of drug metabolizing enzyme 28 days before screening or during the study, including strong inhibitors and inducers that affect the metabolizing enzyme; Took any prescription drugs or herbs within 14 days before screening, or took over-the-counter drugs or any vitamin products within 7 days before screening; Vaccinated within 14 days before screening or planned to be vaccinated during the study; Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening; Those who cannot tolerate high fat (about 50% of the total calories) and high calorie (about 800~1000 calories) standard meals (only applies to subjects participating in the food effect study); Abnormal ECG has clinical significance; Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study; Clinical laboratory examinations are abnormal and clinically significant, or find the following diseases with clinical significance (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease) within 6 months before screening; Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody; Acute disease or concomitant medication occurs from the screening stage to before study medication; Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug; People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years; The investigator believes that there are other subjects who are not suitable for participating in this trial.

Sites / Locations

  • The first hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment A

Treatment B

Arm Description

Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing.

Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing.

Outcomes

Primary Outcome Measures

Cmax
Maximum Observed Plasma Concentration (Cmax) of GST-HG171
AUCinf
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of GST-HG171
AUClast
Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of GST-HG171

Secondary Outcome Measures

urine
Total recovery of GST-HG171 -related substances in urine
feces
Total recovery of GST-HG171 -related substances in feces

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Fujian Akeylink Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06084507
Brief Title
Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
Official Title
Food Effects Study of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
December 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Akeylink Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A single-center, randomized, open, single-dose, two-cycle, two-sequence, cross-over study was conducted to evaluate the effect of food on the pharmacokinetic characteristics of GST-HG171 in combination with Ritonavir.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Experimental
Arm Description
Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fasted conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing.
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
Single oral dose of ritonavir at -12 hours prior to GST-HG171/ritonavir dosing, followed by single oral dose of GST-HG171/ritonavir under fed conditions. Ritonavir will continue to be dosed at 12 hours and 24 hours GST-HG171 dosing.
Intervention Type
Drug
Intervention Name(s)
GST-HG171/ritonavir
Intervention Description
Single oral dose of GST-HG171 300 mg (2 × 150 mg tablets)/ritonavir 100 mg under fed or fasted conditions at 0 hour on Day 1
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Description
Single oral dose of ritonavir 100 mg at -12 hours prior to GST-HG171/ritonavir dosing, and ritonavir 100 mg will be dosed at 12 hours and 24 hours after GST-HG171/ritonavir dosing.
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum Observed Plasma Concentration (Cmax) of GST-HG171
Time Frame
Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose
Title
AUCinf
Description
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of GST-HG171
Time Frame
Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose
Title
AUClast
Description
Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of GST-HG171
Time Frame
Day 1 pre-dose, 0.25、0.5、0.75、1、1.25、1.5、2、3、4、6、8、12、24、48 and 72 hour post-dose
Secondary Outcome Measure Information:
Title
urine
Description
Total recovery of GST-HG171 -related substances in urine
Time Frame
120 hours from GST-HG171 administration
Title
feces
Description
Total recovery of GST-HG171 -related substances in feces
Time Frame
120 hours from GST-HG171 administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial; Ability to complete research in accordance with test plan requirements; Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration; Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old); Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 ~ 28 kg / m2 (including critical value); Physical examination, normal or abnormal vital signs have no clinical significance Exclusion Criteria: Allergies (multiple drugs and food allergies); Those who smoked more than 5 cigarettes per day in the 3 months before the trial; Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); Blood donation or massive blood loss (> 400 mL) within three months before screening; Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including a history of frequent nausea or vomiting caused by any cause; Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug; Have Intended to take any drug that changes the activity of drug metabolizing enzyme 28 days before screening or during the study, including strong inhibitors and inducers that affect the metabolizing enzyme; Took any prescription drugs or herbs within 14 days before screening, or took over-the-counter drugs or any vitamin products within 7 days before screening; Vaccinated within 14 days before screening or planned to be vaccinated during the study; Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening; Those who cannot tolerate high fat (about 50% of the total calories) and high calorie (about 800~1000 calories) standard meals (only applies to subjects participating in the food effect study); Abnormal ECG has clinical significance; Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study; Clinical laboratory examinations are abnormal and clinically significant, or find the following diseases with clinical significance (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease) within 6 months before screening; Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody; Acute disease or concomitant medication occurs from the screening stage to before study medication; Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug; People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years; The investigator believes that there are other subjects who are not suitable for participating in this trial.
Facility Information:
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants

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