COVID-19 Respiratory InfectionPhase 1NCT06084507
Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
A Phase 1 study testing GST-HG171/ritonavir and ritonavir in people with COVID-19 Respiratory Infection, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- GST-HG171/ritonavir and ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2023to 27 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Effects Study of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
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.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- GST-HG171/ritonavir, ritonavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GST-HG171/ritonavir; Drug: 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. Receives: Drug: GST-HG171/ritonavir; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Plasma Concentration (Cmax) of GST-HG171
Measured: 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
Measured: 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
Measured: 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
Total recovery of GST-HG171 -related substances in urine
Measured: 120 hours from GST-HG171 administration
feces
Total recovery of GST-HG171 -related substances in feces
Measured: 120 hours from GST-HG171 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start4 May 2023
- Primary completion23 May 2023
- Study completion27 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084507
- Sponsor's protocol ID
- GST-HG171-I-06
- Status last verified
- May 2023
- First submitted
- 10 Oct 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Effects Study of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT06084507
- Acronym / sponsor ID
- GST-HG171-I-06
- Conditions
- COVID-19 Respiratory Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 27 Dec 2023 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: GST-HG171/ritonavir, Drug: ritonavirSingle 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. |
| Treatment B | Experimental | Drug: GST-HG171/ritonavir, Drug: ritonavirSingle 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GST-HG171/ritonavirSingle 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 | Drug | Treatment A, Treatment B |
| ritonavirSingle 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. | Drug | Treatment A, Treatment B |
Primary outcome
Cmax
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
Maximum Observed Plasma Concentration (Cmax) of GST-HG171
AUCinf
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
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of GST-HG171
AUClast
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
Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of GST-HG171
2 secondary outcomes
urine
Time frame: 120 hours from GST-HG171 administration
feces
Time frame: 120 hours from GST-HG171 administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GST-HG171/ritonavir and ritonavir in people with COVID-19 Respiratory Infection, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.