Pancreatic CancerPhase 1NCT07906691
A Study to Assess the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Following Intravenous Infusion in Healthy Participants
A Phase 1 study testing HRS4642 and Itraconazole Capsules in people with Pancreatic Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
HRS-4642-103 is a single-center, single-arm, open-label, fixed-sequence study to investigate the effect of Itraconazole on the pharmacokinetics of HRS-4642 following intravenous infusion in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HRS4642 and Itraconazole Capsules
- 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
- Nov 2026to May 2027
- 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 body weight ≥ 50.0 kg, female participants with body weight ≥ 45.0 kg, and body mass index (BMI) between 19 and 26 kg/m² (inclusive of both endpoints).
- Female participants of childbearing potential who have not been surgically sterilized must use highly effective contraception from the time of signing the informed consent form until 1 month after the last dose of HRS-4642; male participants whose partners are women of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 1 month after the last dose of HRS-4642. Female participants of childbearing potential who have not been surgically sterilized must have a negative serum HCG test within 14 days prior to the first dose, and must not be lactating.
- Participants are able to communicate effectively with the investigator, understand and comply with all requirements of this study, and understand and sign the informed consent form.
Who cannot join
- A history of or current presence of any clinically significant disease of the circulatory, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, or psychiatric systems, or metabolic disorders, or any other condition that may interfere with the study results.
- Poorly controlled or severe cardiovascular/cerebrovascular disease or arterial/venous thrombotic events within 6 months prior to study entry, such as cerebral hemorrhage, cerebral infarction, severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA Class II-IV), myocardial infarction, arrhythmia requiring clinical intervention, deep vein thrombosis, etc.
- Carotid ultrasound showing stenosis ≥ 50% (the ECST method is preferred) or presence of more than 2 high-risk plaques.
- Surgery within 6 months prior to screening, or planned surgery during the study period.
- Previous surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, gastric bypass/bariatric surgery, etc.), or need for gastric acid-neutralizing medications (e.g., aluminum hydroxide) during the study.
- Blood donation or significant blood loss (≥ 400 mL), blood transfusion, or use of blood products within 3 months prior to screening.
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- Regular use of sedatives, hypnotics, or other addictive drugs; a history of drug abuse within 1 year prior to screening, or a positive urine drug abuse screen.
- Participation in any clinical trial with administration of investigational drugs within 3 months prior to the first dose.
- Smoking more than 5 cigarettes per day within 3 months prior to screening, and inability to stop using any tobacco products during the study period.
- Regular alcohol consumption within 6 months prior to screening, defined as more than 14 units of alcohol per week (1 unit = 285 mL of beer, 25 mL of spirits, or 100 mL of wine), and inability to stop using any alcohol-containing products during the study period; positive breath alcohol test.
- Clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram (ECG), abdominal ultrasound, chest X-ray, complete blood count, blood biochemistry, urinalysis, or coagulation tests during the screening period.
- Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (anti-HCV), positive syphilis antibody, or positive HIV antibody.
- History of needle phobia or blood-injection phobia, difficulty with blood collection, or inability to tolerate venipuncture blood sampling.
- Pregnant or lactating women.
- Participants with other factors deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Third Hospital of Central South University
Changsha, Hunan, 410013
Guoping Yang, +86-0731-89918665, ygp9880@163.com
Guoping Yang
About this study
Official title: A Single-Center, Open-Label, Fixed-Sequence, Single-Arm Study to Assess the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Following Intravenous Infusion in Healthy Participants
HRS-4642-103 is a single-center, single-arm, open-label, fixed-sequence study to investigate the effect of Itraconazole on the pharmacokinetics of HRS-4642 following intravenous infusion in healthy participants.
- Conditions
- Pancreatic Cancer
- Being tested
- HRS4642, Itraconazole Capsules
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS4642Drug
HRS4642.
Itraconazole CapsulesDrug
Itraconazole capsules.
| Study group | Role | What they receive |
|---|---|---|
| HRS4642 + Itraconazole capsules Group | Experimental | Healthy subjects received HRS4642 and itraconazole capsules. Receives: Drug: HRS4642; Drug: Itraconazole Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax)
Measured: Post-dose at Day 1 to Day 44.
Area under the blood drug concentration-time curve from time 0 corresponding to the last quantifiable concentration time (AUC0-t)
Measured: Post-dose at Day 1 to Day 44.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC₀-∞)
Measured: Post-dose at Day 1 to Day 44.
Secondary outcomes (7)
Time to maximum plasma concentration (Tmax)
Measured: Post-dose at Day 1 to Day 44.
Terminal half-life (t1/2)
Measured: Post-dose at Day 1 to Day 44.
Terminal elimination rate constant (λz)
Measured: Post-dose at Day 1 to Day 44.
Volume of distribution at steady state (Vss)
Measured: Post-dose at Day 1 to Day 44.
Total systemic clearance / Total body clearance (CL)
Measured: Post-dose at Day 1 to Day 44.
Percentage of AUC extrapolated from the last measurable concentration to infinity (AUC_%Extrap)
Measured: Post-dose at Day 1 to Day 44.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Valuated by laboratory tests, electrocardiograms, vital signs, physical examinations, etc.
Measured: Screening period up to Day 44.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single-arm, open, fixed sequence study.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906691
- Sponsor's protocol ID
- HRS-4642-103
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Fixed-Sequence, Single-Arm Study to Assess the Effect of Itraconazole on the Pharmacokinetics of HRS-4642 Following Intravenous Infusion in Healthy Participants
- ClinicalTrials.gov ID
- NCT07906691
- Acronym / sponsor ID
- HRS-4642-103
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 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.
HRS-4642-103 is a single-center, single-arm, open-label, fixed-sequence study to investigate the effect of Itraconazole on the pharmacokinetics of HRS-4642 following intravenous infusion in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single-arm, open, fixed sequence study.
| Arm | Type | Receives |
|---|---|---|
| HRS4642 + Itraconazole capsules Group | Experimental | Drug: HRS4642, Drug: Itraconazole CapsulesHealthy subjects received HRS4642 and itraconazole capsules. |
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 body weight ≥ 50.0 kg, female participants with body weight ≥ 45.0 kg, and body mass index (BMI) between 19 and 26 kg/m² (inclusive of both endpoints).
- Female participants of childbearing potential who have not been surgically sterilized must use highly effective contraception from the time of signing the informed consent form until 1 month after the last dose of HRS-4642; male participants whose partners are women of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 1 month after the last dose of HRS-4642. Female participants of childbearing potential who have not been surgically sterilized must have a negative serum HCG test within 14 days prior to the first dose, and must not be lactating.
- Participants are able to communicate effectively with the investigator, understand and comply with all requirements of this study, and understand and sign the informed consent form.
Key exclusion criteria (15 listed)
- A history of or current presence of any clinically significant disease of the circulatory, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, or psychiatric systems, or metabolic disorders, or any other condition that may interfere with the study results.
- Poorly controlled or severe cardiovascular/cerebrovascular disease or arterial/venous thrombotic events within 6 months prior to study entry, such as cerebral hemorrhage, cerebral infarction, severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA Class II-IV), myocardial infarction, arrhythmia requiring clinical intervention, deep vein thrombosis, etc.
- Carotid ultrasound showing stenosis ≥ 50% (the ECST method is preferred) or presence of more than 2 high-risk plaques.
- Surgery within 6 months prior to screening, or planned surgery during the study period.
- Previous surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, gastric bypass/bariatric surgery, etc.), or need for gastric acid-neutralizing medications (e.g., aluminum hydroxide) 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 |
|---|---|---|
| HRS4642HRS4642. | Drug | HRS4642 + Itraconazole capsules Group |
| Itraconazole CapsulesItraconazole capsules. | Drug | HRS4642 + Itraconazole capsules Group |
Primary outcome
The maximum plasma concentration (Cmax)
Time frame: Post-dose at Day 1 to Day 44.
Area under the blood drug concentration-time curve from time 0 corresponding to the last quantifiable concentration time (AUC0-t)
Time frame: Post-dose at Day 1 to Day 44.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC₀-∞)
Time frame: Post-dose at Day 1 to Day 44.
7 secondary outcomes
Time to maximum plasma concentration (Tmax)
Time frame: Post-dose at Day 1 to Day 44.
Terminal half-life (t1/2)
Time frame: Post-dose at Day 1 to Day 44.
Terminal elimination rate constant (λz)
Time frame: Post-dose at Day 1 to Day 44.
Volume of distribution at steady state (Vss)
Time frame: Post-dose at Day 1 to Day 44.
Total systemic clearance / Total body clearance (CL)
Time frame: Post-dose at Day 1 to Day 44.
Percentage of AUC extrapolated from the last measurable concentration to infinity (AUC_%Extrap)
Time frame: Post-dose at Day 1 to Day 44.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Screening period up to Day 44.
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 30 Oct 2026.
- 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.
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 HRS4642 and Itraconazole Capsules in people with Pancreatic Cancer, run by Shanghai Hengrui Pharmaceutical 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 4 inclusion and 15 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 30 Oct 2026. 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?
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?
Contact Fen Yao (+86-0518-82342973, fen.yao.fy3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum plasma concentration (Cmax) (time frame: Post-dose at Day 1 to Day 44.). 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 30 Oct 2026.