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Active, not recruitingNCT06084507Updated Oct 16, 2023

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

A Phase 1 interventional study of GST-HG171/ritonavir and ritonavir in COVID-19 Respiratory Infection, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by Fujian Akeylink Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2023, registered Oct 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19 Respiratory Infection
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's planned enrollment of 18 is below the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Fujian Akeylink Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
  2. Ability to complete research in accordance with test plan requirements;
  3. Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
  4. Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old);
  5. 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);
  6. Physical examination, normal or abnormal vital signs have no clinical significance

Exclusion criteria

Exclusion Criteria:

  1. Allergies (multiple drugs and food allergies);
  2. Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
  3. 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);
  4. Blood donation or massive blood loss (> 400 mL) within three months before screening;
  5. 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;
  6. Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
  7. Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
  8. 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;
  9. 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;
  10. Vaccinated within 14 days before screening or planned to be vaccinated during the study;
  11. 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;
  12. 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);
  13. Abnormal ECG has clinical significance;
  14. Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study;
  15. 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;
  16. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;
  17. Acute disease or concomitant medication occurs from the screening stage to before study medication;
  18. Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
  19. People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
  20. The investigator believes that there are other subjects who are not suitable for participating in this trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Treatment A

    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/ritonavir · Drug: ritonavir

  • Experimental
    Treatment B

    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/ritonavir · Drug: ritonavir

Interventions

  • DrugGST-HG171/ritonavir

    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

  • Drugritonavir

    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.

06

What researchers measure

Primary outcomes

  1. Cmax

    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

  2. AUCinf

    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

  3. AUClast

    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 outcomes

  1. urine

    Total recovery of GST-HG171 -related substances in urine

    Time frame: 120 hours from GST-HG171 administration

  2. feces

    Total recovery of GST-HG171 -related substances in feces

    Time frame: 120 hours from GST-HG171 administration

07

Study locations

1 site
  • The first hospital of Jilin University
    Changchun, Jilin 130021, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06084507
Lead sponsor
Fujian Akeylink Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Oct 16, 2023
Start date
May 4, 2023
Primary completion
May 23, 2023
Completion
Dec 27, 2023 (estimated)
Last update
Oct 16, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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