Healthy ParticipantPhase 1NCT06087055
Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants
A Phase 1 study testing GST-HG171/Ritonavir and Itraconazole in people with Healthy Participant, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant
- What is being tested?
- GST-HG171/Ritonavir and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 7 Aug 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;
- 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: An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole With GST-HG171/Ritonavir in Healthy Adult Chinese Participants
The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.
- Conditions
- Healthy Participant
- Being tested
- GST-HG171/Ritonavir, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG171/RitonavirDrug
Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
ItraconazoleDrug
Administered orally once daily for 9 days from Days 8 through 16
GST-HG171/RitonavirDrug
Administered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | GST-HG171/ritonavir orally Receives: Drug: GST-HG171/Ritonavir |
| Period 2 | Experimental | Itraconazole+GST-HG171/ritonavir orally Receives: Drug: Itraconazole; Drug: GST-HG171/Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of GST-HG171
The Cmax of GST-HG171 in the study was observed directly from data.
Measured: Days 2(pre-dose), 3 (pre-dose,0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24 and 48 hours postdose on Day 3) in Period 1; Days 13(pre-dose), Days 14 (pre-dose, 0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24,48, and 72 hours postdose on Day 14) of Period 2.
Secondary outcomes (1)
AEs
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Screening up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start12 May 2023
- Primary completion5 Jun 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT06087055
- Sponsor's protocol ID
- GST-HG171-I-04
- Status last verified
- May 2023
- First submitted
- 11 Oct 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li X, Li B, Wang M, Wang J, Lu J, Mao J, Zhang T, Tang Y, Yan W, Li C, Zhang G, Ding Y. Pharmacokinetic drug-drug interaction between the COVID-19 3CL protease inhibitor GST-HG171 and itraconazole in healthy subjects. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0028526. doi: 10.1128/aac.00285-26. Epub 2026 May 11.
PubMed 42112804
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labe Study to Evaluate the Drug-Drug Interaction of Itraconazole With GST-HG171/Ritonavir in Healthy Adult Chinese Participants
- ClinicalTrials.gov ID
- NCT06087055
- Acronym / sponsor ID
- GST-HG171-I-04
- Conditions
- Healthy Participant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 5 Jun 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 17 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.
The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of GST-HG171/ritonavir in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: GST-HG171/RitonavirGST-HG171/ritonavir orally |
| Period 2 | Experimental | Drug: Itraconazole, Drug: GST-HG171/RitonavirItraconazole+GST-HG171/ritonavir orally |
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 (19 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/RitonavirAdministered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3 | Drug | Period 1 |
| ItraconazoleAdministered orally once daily for 9 days from Days 8 through 16 | Drug | Period 2 |
| GST-HG171/RitonavirAdministered orally BID for 3 day for a total on 5 doses starting on Day 12 through Day 14 | Drug | Period 2 |
Primary outcome
Maximum Observed Concentration (Cmax) of GST-HG171
Time frame: Days 2(pre-dose), 3 (pre-dose,0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24 and 48 hours postdose on Day 3) in Period 1; Days 13(pre-dose), Days 14 (pre-dose, 0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24,48, and 72 hours postdose on Day 14) of Period 2.
The Cmax of GST-HG171 in the study was observed directly from data.
1 secondary outcome
AEs
Time frame: Screening up to Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Derived from this study: PubMed 42112804Li X, Li B, Wang M, Wang J, Lu J, Mao J, Zhang T, Tang Y, Yan W, Li C, Zhang G, Ding Y. Pharmacokinetic drug-drug interaction between the COVID-19 3CL protease inhibitor GST-HG171 and itraconazole in healthy subjects. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0028526. doi: 10.1128/aac.00285-26. Epub 2026 May 11.
- Individual participant dataSharing planned: Undecided
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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 Itraconazole in people with Healthy Participant, 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 19 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: finished, as of the sponsor's last update on 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Observed Concentration (Cmax) of GST-HG171 (time frame: Days 2(pre-dose), 3 (pre-dose,0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24 and 48 hours postdose on Day 3) in Period 1; Days 13(pre-dose), Days 14 (pre-dose, 0.25,0.5,0.75,1,1.25 ,1.5,2,3 ,4 ,6,8,12 ,24,48, and 72 hours postdose on Day 14) of Period 2.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087055, which also lists 1 linked publication.
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 17 Oct 2023.