Drug InteractionsPhase 1NCT07894679
Effect of Itraconazole on the Pharmacokinetics of Intravenous HRS-4642 in Healthy Participants
A Phase 1 study testing HRS-4642 and Itraconazole (200 mg) in people with Drug Interactions, run by The Third Xiangya Hospital of Central South University.
Trial summary
This is a Phase 1, single-center, open-label study designed to evaluate the effect of itraconazole on the pharmacokinetics of HRS-4642 in healthy adult participants. Approximately 18 healthy participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions
- What is being tested?
- HRS-4642 and Itraconazole (200 mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
- Male participants with a body weight of at least 50.0 kg and female participants with a body weight of at least 45.0 kg, and a body mass index between 19 and 26 kg/m² (inclusive).
- Women of childbearing potential who have not undergone surgical sterilization must use highly effective contraception from signing the informed consent form until 1 month after the last dose of HRS-4642. Male participants with female partners of childbearing potential must also use highly effective contraception during the same period. Women of childbearing potential must have a negative serum human chorionic gonadotropin test within 14 days before the first dose and must not be breastfeeding.
- Participants who are able to communicate effectively with the investigator, understand and comply with all study requirements, and voluntarily sign the informed consent form.
Who cannot join
- History or presence of any clinically significant serious disease involving the cardiovascular, endocrine, neurological, gastrointestinal, respiratory, genitourinary, hematological, immunological, psychiatric, or metabolic systems, or any other condition that may interfere with the study results.
- Poorly controlled or severe cardiovascular or cerebrovascular disease, or arterial or venous thrombotic events within 6 months before study entry, including cerebral hemorrhage, cerebral infarction, severe or unstable angina, symptomatic congestive heart failure (New York Heart Association Class II-IV), myocardial infarction, arrhythmias requiring medical intervention, or deep vein thrombosis.
- Carotid artery stenosis of at least 50% on ultrasonography (preferably assessed using the European Carotid Surgery Trial method), or the presence of more than two high-risk plaque features.
- Low-density lipoprotein cholesterol, total cholesterol, or triglyceride levels above the upper limit of the study site's reference range at screening, or moderate or higher risk of atherosclerotic cardiovascular disease as assessed by the investigator according to the Chinese Guidelines for Lipid Management (2023).
- History of surgery within 6 months before screening or planned surgery during the study.
- History of any surgery affecting gastrointestinal absorption, including gastrectomy, intestinal resection, or bariatric surgery, or a need for gastric acid-neutralizing medications during the study.
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- Blood donation or significant blood loss of at least 400 mL, blood transfusion, or use of blood products within 3 months before screening.
- History of severe drug allergy or hypersensitivity reactions, or known hypersensitivity to HRS-4642 injection, itraconazole, or any of their excipients.
- Regular use of sedatives, hypnotics, or other addictive medications; history of drug abuse within 1 year before screening; or a positive urine drug abuse screening test.
- Use of potentially hepatotoxic medications, such as dapsone, erythromycin, fluconazole, ketoconazole, or rifampicin, for more than 7 consecutive days within 6 months before screening.
- Participation in any clinical trial involving administration of an investigational drug within 3 months before the first dose.
- Use of medications affecting hepatic enzyme activity or P-glycoprotein activity within 28 days before administration of the study drug.
- Use of any prescription medications or traditional herbal supplements within 1 month before the first dose, or any over-the-counter medications or dietary supplements, including vitamins and calcium supplements, within 2 weeks before the first dose.
- Smoking more than 5 cigarettes per day within 3 months before screening and inability to abstain from tobacco products during the study.
- Regular alcohol consumption exceeding 14 units per week within 6 months before screening and inability to abstain from alcohol during the study, or a positive alcohol breath test. One unit of alcohol is equivalent to 285 mL of beer, 25 mL of spirits, or 100 mL of wine.
- Clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram, abdominal ultrasonography, chest radiography, hematology, blood biochemistry, urinalysis, or coagulation tests during screening.
- Positive screening results for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus antibody.
- Consumption of and unwillingness to abstain from methylxanthine-containing foods or beverages, such as coffee, tea, cola, or chocolate, from 48 hours before the first dose until study withdrawal; consumption of and unwillingness to abstain from grapefruit-containing foods or beverages from 14 days before the first dose until study withdrawal; or special dietary requirements that prevent compliance with standardized meals.
- History of fainting in response to needles or blood, difficulty with blood collection, or inability to tolerate venipuncture.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
About this study
Official title: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Injection Following Intravenous Infusion in Healthy Participants
This is a Phase 1, single-center, open-label study designed to evaluate the effect of itraconazole on the pharmacokinetics of HRS-4642 in healthy adult participants.
Approximately 18 healthy participants will be enrolled. Each participant will receive HRS-4642 alone by intravenous infusion, followed by HRS-4642 in combination with oral itraconazole. Blood samples will be collected to measure HRS-4642 concentrations and assess whether itraconazole affects how HRS-4642 is processed by the body.
The safety of HRS-4642 administered alone and in combination with itraconazole will also be evaluated throughout the study.
Read the detailed description
This is a Phase 1, single-center, single-arm, open-label, fixed-sequence study to evaluate the effect of itraconazole on the pharmacokinetics of HRS-4642 following intravenous infusion in healthy adult participants.
Approximately 18 healthy participants aged 18 to 45 years will be enrolled.
On Day 1, participants will receive a single 200 mg dose of HRS-4642 by intravenous infusion. Blood samples for pharmacokinetic assessment will be collected through Day 17.
From Day 18 to Day 36, participants will receive itraconazole 200 mg orally once daily. On Day 21, participants will receive a second 200 mg intravenous infusion of HRS-4642 in combination with itraconazole. Blood samples for pharmacokinetic assessment will be collected through Day 37.
Pharmacokinetic parameters of HRS-4642 following administration alone and in combination with itraconazole will be evaluated to assess the potential drug-drug interaction.
Safety assessments will include adverse events, physical examinations, vital signs, laboratory tests, and 12-lead electrocardiograms. Participants will undergo safety follow-up after completion of study treatment.
- Conditions
- Drug Interactions
- Being tested
- HRS-4642, Itraconazole (200 mg)
- Keywords
- Drugs, interacting drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4642Drug
HRS-4642 injection will be administered at a dose of 200 mg by intravenous infusion on Day 1 and Day 21. The recommended infusion duration is 100 ± 10 minutes, including flushing.
Itraconazole (200 mg)Drug
Itraconazole capsules will be administered orally at a dose of 200 mg once daily after breakfast from Day 18 through Day 36, for a total of 19 days. On Day 21, HRS-4642 will be administered by intravenous infusion within 10 minutes after oral administration of itraconazole.
| Study group | Role | What they receive |
|---|---|---|
| HRS-4642 Alone and With Itraconazole | Experimental | All participants will receive a single 200 mg intravenous infusion of HRS-4642 on Day 1. Itraconazole 200 mg will be administered orally once daily from Day 18 to Day 36. On Day 21, participants will receive a second 200 mg intravenous infusion of HRS-4642 in combination with itraconazole. Receives: Drug: HRS-4642; Drug: Itraconazole (200 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Total HRS-4642 Following Administration Alone
The maximum observed plasma concentration of total HRS-4642 following a single intravenous infusion of HRS-4642 alone, determined from the plasma concentration-time profile.
Measured: From within 30 minutes before HRS-4642 infusion on Day 1 through 384 hours after completion of the infusion (Day 17).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894679
- Sponsor's protocol ID
- HRS-4642-103
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Injection Following Intravenous Infusion in Healthy Participants
- ClinicalTrials.gov ID
- NCT07894679
- Acronym / sponsor ID
- HRS-4642-103
- Conditions
- Drug Interactions
- Keywords
- Drugs, interacting drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Oct 2026 (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.
This is a Phase 1, single-center, open-label study designed to evaluate the effect of itraconazole on the pharmacokinetics of HRS-4642 in healthy adult participants.
Approximately 18 healthy participants will be enrolled. Each participant will receive HRS-4642 alone by intravenous infusion, followed by HRS-4642 in combination with oral itraconazole. Blood samples will be collected to measure HRS-4642 concentrations and assess whether itraconazole affects how HRS-4642 is processed by the body.
The safety of HRS-4642 administered alone and in combination with itraconazole will also be evaluated throughout the study.
Detailed description
This is a Phase 1, single-center, single-arm, open-label, fixed-sequence study to evaluate the effect of itraconazole on the pharmacokinetics of HRS-4642 following intravenous infusion in healthy adult participants.
Approximately 18 healthy participants aged 18 to 45 years will be enrolled.
On Day 1, participants will receive a single 200 mg dose of HRS-4642 by intravenous infusion. Blood samples for pharmacokinetic assessment will be collected through Day 17.
From Day 18 to Day 36, participants will receive itraconazole 200 mg orally once daily. On Day 21, participants will receive a second 200 mg intravenous infusion of HRS-4642 in combination with itraconazole. Blood samples for pharmacokinetic assessment will be collected through Day 37.
Pharmacokinetic parameters of HRS-4642 following administration alone and in combination with itraconazole will be evaluated to assess the potential drug-drug interaction.
Safety assessments will include adverse events, physical examinations, vital signs, laboratory tests, and 12-lead electrocardiograms. Participants will undergo safety follow-up after completion of study treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-4642 Alone and With Itraconazole | Experimental | Drug: HRS-4642, Drug: Itraconazole (200 mg)All participants will receive a single 200 mg intravenous infusion of HRS-4642 on Day 1. Itraconazole 200 mg will be administered orally once daily from Day 18 to Day 36. On Day 21, participants will receive a second 200 mg intravenous infusion of HRS-4642 in combination with itraconazole. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy participants aged 18 to 45 years (inclusive) at the time of signing the informed consent form.
- Male participants with a body weight of at least 50.0 kg and female participants with a body weight of at least 45.0 kg, and a body mass index between 19 and 26 kg/m² (inclusive).
- Women of childbearing potential who have not undergone surgical sterilization must use highly effective contraception from signing the informed consent form until 1 month after the last dose of HRS-4642. Male participants with female partners of childbearing potential must also use highly effective contraception during the same period. Women of childbearing potential must have a negative serum human chorionic gonadotropin test within 14 days before the first dose and must not be breastfeeding.
- Participants who are able to communicate effectively with the investigator, understand and comply with all study requirements, and voluntarily sign the informed consent form.
Key exclusion criteria (21 listed)
- History or presence of any clinically significant serious disease involving the cardiovascular, endocrine, neurological, gastrointestinal, respiratory, genitourinary, hematological, immunological, psychiatric, or metabolic systems, or any other condition that may interfere with the study results.
- Poorly controlled or severe cardiovascular or cerebrovascular disease, or arterial or venous thrombotic events within 6 months before study entry, including cerebral hemorrhage, cerebral infarction, severe or unstable angina, symptomatic congestive heart failure (New York Heart Association Class II-IV), myocardial infarction, arrhythmias requiring medical intervention, or deep vein thrombosis.
- Carotid artery stenosis of at least 50% on ultrasonography (preferably assessed using the European Carotid Surgery Trial method), or the presence of more than two high-risk plaque features.
- Low-density lipoprotein cholesterol, total cholesterol, or triglyceride levels above the upper limit of the study site's reference range at screening, or moderate or higher risk of atherosclerotic cardiovascular disease as assessed by the investigator according to the Chinese Guidelines for Lipid Management (2023).
- History of surgery within 6 months before screening or planned surgery during the study.
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 |
|---|---|---|
| HRS-4642HRS-4642 injection will be administered at a dose of 200 mg by intravenous infusion on Day 1 and Day 21. The recommended infusion duration is 100 ± 10 minutes, including flushing. | Drug | HRS-4642 Alone and With Itraconazole |
| Itraconazole (200 mg)Itraconazole capsules will be administered orally at a dose of 200 mg once daily after breakfast from Day 18 through Day 36, for a total of 19 days. On Day 21, HRS-4642 will be administered by intravenous infusion within 10 minutes after oral administration of itraconazole. | Drug | HRS-4642 Alone and With Itraconazole |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Total HRS-4642 Following Administration Alone
Time frame: From within 30 minutes before HRS-4642 infusion on Day 1 through 384 hours after completion of the infusion (Day 17).
The maximum observed plasma concentration of total HRS-4642 following a single intravenous infusion of HRS-4642 alone, determined from the plasma concentration-time profile.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-4642 and Itraconazole (200 mg) in people with Drug Interactions, run by The Third Xiangya Hospital of Central South University.
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 4 inclusion and 21 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 Plasma Concentration (Cmax) of Total HRS-4642 Following Administration Alone (time frame: From within 30 minutes before HRS-4642 infusion on Day 1 through 384 hours after completion of the infusion (Day 17).). 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 26 Oct 2026.