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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started May 2023

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

May 4, 2023

Completed

19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed

Last Updated

October 16, 2023

Status Verified

May 1, 2023

Enrollment Period

19 days

First QC Date

October 10, 2023

Last Update Submit

October 10, 2023

Conditions

COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (3)

Cmax
Maximum Observed Plasma Concentration (Cmax) of GST-HG171
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
AUCinf
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of GST-HG171
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
AUClast
Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of GST-HG171
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 Outcomes (2)

urine
120 hours from GST-HG171 administration
feces
120 hours from GST-HG171 administration

Study Arms (2)

Treatment A

EXPERIMENTAL

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.

Drug: GST-HG171/ritonavirDrug: ritonavir

Treatment B

EXPERIMENTAL

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.

Drug: GST-HG171/ritonavirDrug: ritonavir

Interventions

GST-HG171/ritonavirDRUG

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

Treatment ATreatment B

ritonavirDRUG

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.

Treatment ATreatment B

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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;
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Fujian Akeylink Biotechnology Co., Ltd.lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

Ritonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

May 4, 2023

Primary Completion

May 23, 2023

Study Completion

December 27, 2023

Last Updated

October 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Treatment A

Treatment B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations