Health, SubjectivePhase 1NCT07697157
The Study on Effects of CYP3A and P-glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampin of HMPL-453 Tartrate Tablets
A Phase 1 study testing HMPL-453 with Itraconazole and HMPL-453 with Rifampin in people with Health, Subjective, run by Hutchmed at 1 site in China.
Trial summary
Primary objective： 1. To evaluate the effect of Itraconazole ( CYP3A and P-gp inhibitors) on HMPL-453 pharmacokinetics(PK) in healthy subjects 2. To evaluate the effect of Rifampin (CYP enzyme inducer) on HMPL-453 pharmacokinetics (PK) in healthy subjects Secondary objectives： To evaluate the safety of HMPL-453 with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- HMPL-453 with Itraconazole and HMPL-453 with Rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has fully understood and voluntarily signed the ICF for this study.
- Male or female 18 years of age or older.
- Body mass index (BMI) at screening: 18 < BMI ≤ 29.9 kg/m 2 and weight ≥ 50 kg for men and ≥ 45 kg for women.
- Female subjects of childbearing potential use highly effective contraception from 1 month prior to signing ICF through 6 months following the last HMPL-453 dose and agree not to donate ova for reproductive purposes during this period (or oocytes). Acceptable forms of highly effective contraception include total abstinence, bilateral tubal ligation, oral or injectable contraceptives, intrauterine devices, or vasectomy in the partner. All hormonal contraception must be combined with barrier measures such as condom use by the spouse.
- Male subjects agree to use highly effective contraception from first dose until 3 months after the last HMPL-453 dose. Subjects should refrain from donating or freezing sperm during this period .
- Subject is willing and able to comply with the protocol in all aspects.
Who cannot join
- Patients with previous or excluded diseases with abnormal clinical manifestations during the screening period, including but not limited to neurological/psychiatric system, respiratory system, cardiovascular and cerebrovascular system, gastrointestinal system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, liver and kidney function, endocrine system, and immune system diseases.
- Subjects with clinically significant (eg, requiring medical intervention or surgical treatment) disease within 8 weeks or clinically significant (requiring systemic anti-infective treatment, such as oral or intravenous antiviral, antibacterial, antifungal therapy, etc) infection within 4 weeks prior to the first dose.
- Subject has a current or past history of retinal detachment.
- Use of any medications (including prescription drugs, over-the-counter drugs, herbal preparations and formulas, etc.) and health products within 2 weeks prior to the first dose.
- Hypericum perforatum requiring 4 weeks or 5 half-lives (whichever is longer) prior to first dose 3 weeks) Use of any drugs that inhibit or induce cytochrome P450 enzymes or P- glycoprotein inhibitors (See Appendix 12.3 for details).
- Subject has received blood or blood products 4 weeks prior to first dose and donated blood or blood products 8 weeks prior to first dose.
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- Subjects who cannot guarantee not to take any food, juice or beverage containing alcohol, grapefruit, Seville oranges and caffeine within 72 hours prior to the first dose until the end of the trial; and have special requirements for diet and cannot comply with the unified diet.
- Smoking more than 10 cigarettes per day within 3 months prior to screening and unable to completely abstain from smoking during the study.
- Regular drinkers 6 months prior to screening, defined as drinking more than 14 units of alcohol per week ( 1 units = 360 mL Beer or 45 mL spirits or 150 mL wine containing 40% alcohol; positive alcohol screen.
- Participated in other clinical trials of drugs or medical devices 3 months before taking study drug, or failed online screening.
- Fainting, halo, or difficulty collecting venous blood.
- Subject is hypersensitive to any of the study medications (or their excipients) administered in this study.
- Female subject is pregnant or lactating, or has a positive pregnancy test result.
- The subject had clinically significant abnormalities in physical examination, abdominal B scan (hepatobiliary pancreatic splenorenal), and laboratory test results at Screening.
- Abnormal vital signs (excluded if any of the following: systolic blood pressure:
- < 90 mmHg or > 140 mmHg , diastolic blood pressure: < 60 mmHg or > 90 mmHg ; pulse: < 60 beats
- /min or > 100 beats/min; Body temperature < 35.8 ° C or > 37.3 ° C (frontal temperature).
- Subjects with keratopathy confirmed by ophthalmic examination, including but not limited to bullous keratopathy, band keratopathy, corneal abrasion, corneal ulcer, keratitis, or other ophthalmic abnormalities considered by the investigator as inappropriate for participation in this study.
- The subject had clinically significant ECG abnormalities, including a prolonged baseline QTcF (eg, QTcF interval > 450 ms in males and QTcF interval > 460 ms in females), or a family history of QTc prolongation syndrome or sudden death. If ECG does not show QTcF results, use the following formula for calculation: QTcF = QT/RR .
- Presence of drug abuse (including morphine, methylenedioxyamphetamine, methylamphetamine, tetrahydrocannabinolic acid, ketamine, cocaine urine drug abuse screen positive) at Screening.
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus Positive (HCV) antibody or syphilis-specific antibody.
- Abnormal chest X-ray (anteroposterior) findings with clinical significance (such as active infection, high-risk nodules, etc.).
- Any other condition that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Two-Part, Two-Period, Fixed Sequence Crossover I Study to Evaluate the Effect of CYP3A and P- Glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampicin on the Pharmacokinetics of HMPL-453 Tartrate Tablets in Healthy Subjects
Primary objective：
- To evaluate the effect of Itraconazole ( CYP3A and P-gp inhibitors) on HMPL-453 pharmacokinetics(PK) in healthy subjects
- To evaluate the effect of Rifampin (CYP enzyme inducer) on HMPL-453 pharmacokinetics (PK) in healthy subjects
Secondary objectives：
To evaluate the safety of HMPL-453 with and without itraconazole or rifampin following a low-fat meal in healthy subjects
Exploratory objectives:
- Assess cholesterol and 4β- hydroxycholesterol in plasma CYP3A4 Biomarker Concentration Levels ;
- Explore proarrhythmic effect of HMPL-453 [Results of exploratory objectives analyses will be reported separately and not included in the clinical trial Study Report (CSR)]
- Conditions
- Health, Subjective
- Being tested
- HMPL-453 with Itraconazole, HMPL-453 with Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMPL-453 with ItraconazoleDrug
HMPL-453: 100mg, D1、D14;
Itraconazole: 400mg, D10;200mg,D11-D22
HMPL-453 with RifampinDrug
HMPL-453: 300mg, D1、D16;
Rifampin: 600mg, D10-D24
| Study group | Role | What they receive |
|---|---|---|
| Part A:HMPL-453 with Itraconazole | Other | Not described Receives: Drug: HMPL-453 with Itraconazole |
| Part B:HMPL-453 with Rifampin | Other | Not described Receives: Drug: HMPL-453 with Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-t
Area under the plasma concentration - time curve from time 0 to time of last measurable concentration
Measured: 25Days
AUC 0- ∞
Area under the plasma concentration - time curve from time 0 extrapolated to infinity
Measured: 25Days
C max
Peak concentration
Measured: 25Days
Secondary outcomes (2)
T max, t 1/2
Additional PK parameters of HMPL-453 , such as time to maximum concentration (T max), terminal elimination half-life (t 1/2), etc.
Measured: 25Days
AE rate
Incidence, severity, seriousness and relatedness of adverse events (AEs), laboratory test results, vital signs, physical examination, 12 lead electrocardiogram (ECG), ophthalmologic examination, etc.
Measured: through study completion, an average of 33days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Mar 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by HutchmedThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697157
- Sponsor's protocol ID
- 2024-453-00CH1
- Status last verified
- Jul 2026
- First submitted
- 5 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Two-Part, Two-Period, Fixed Sequence Crossover I Study to Evaluate the Effect of CYP3A and P- Glycoprotein Inhibitor Itraconazole and CYP Enzyme Inducer Rifampicin on the Pharmacokinetics of HMPL-453 Tartrate Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07697157
- Acronym / sponsor ID
- 2024-453-00CH1
- Conditions
- Health, Subjective
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Jul 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.
Primary objective：
- To evaluate the effect of Itraconazole ( CYP3A and P-gp inhibitors) on HMPL-453 pharmacokinetics(PK) in healthy subjects
- To evaluate the effect of Rifampin (CYP enzyme inducer) on HMPL-453 pharmacokinetics (PK) in healthy subjects
Secondary objectives：
To evaluate the safety of HMPL-453 with and without itraconazole or rifampin following a low-fat meal in healthy subjects
Exploratory objectives:
- Assess cholesterol and 4β- hydroxycholesterol in plasma CYP3A4 Biomarker Concentration Levels ;
- Explore proarrhythmic effect of HMPL-453 [Results of exploratory objectives analyses will be reported separately and not included in the clinical trial Study Report (CSR)]
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A:HMPL-453 with Itraconazole | Other | Drug: HMPL-453 with Itraconazole |
| Part B:HMPL-453 with Rifampin | Other | Drug: HMPL-453 with Rifampin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has fully understood and voluntarily signed the ICF for this study.
- Male or female 18 years of age or older.
- Body mass index (BMI) at screening: 18 < BMI ≤ 29.9 kg/m 2 and weight ≥ 50 kg for men and ≥ 45 kg for women.
- Female subjects of childbearing potential use highly effective contraception from 1 month prior to signing ICF through 6 months following the last HMPL-453 dose and agree not to donate ova for reproductive purposes during this period (or oocytes). Acceptable forms of highly effective contraception include total abstinence, bilateral tubal ligation, oral or injectable contraceptives, intrauterine devices, or vasectomy in the partner. All hormonal contraception must be combined with barrier measures such as condom use by the spouse.
- Male subjects agree to use highly effective contraception from first dose until 3 months after the last HMPL-453 dose. Subjects should refrain from donating or freezing sperm during this period .
Key exclusion criteria (23 listed)
- Patients with previous or excluded diseases with abnormal clinical manifestations during the screening period, including but not limited to neurological/psychiatric system, respiratory system, cardiovascular and cerebrovascular system, gastrointestinal system (any history of gastrointestinal diseases affecting oral or absorption of drugs), blood and lymphatic system, liver and kidney function, endocrine system, and immune system diseases.
- Subjects with clinically significant (eg, requiring medical intervention or surgical treatment) disease within 8 weeks or clinically significant (requiring systemic anti-infective treatment, such as oral or intravenous antiviral, antibacterial, antifungal therapy, etc) infection within 4 weeks prior to the first dose.
- Subject has a current or past history of retinal detachment.
- Use of any medications (including prescription drugs, over-the-counter drugs, herbal preparations and formulas, etc.) and health products within 2 weeks prior to the first dose.
- Hypericum perforatum requiring 4 weeks or 5 half-lives (whichever is longer) prior to first dose 3 weeks) Use of any drugs that inhibit or induce cytochrome P450 enzymes or P- glycoprotein inhibitors (See Appendix 12.3 for details).
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 |
|---|---|---|
| HMPL-453 with ItraconazoleHMPL-453: 100mg, D1、D14; Itraconazole: 400mg, D10;200mg,D11-D22 | Drug | Part A:HMPL-453 with Itraconazole |
| HMPL-453 with RifampinHMPL-453: 300mg, D1、D16; Rifampin: 600mg, D10-D24 | Drug | Part B:HMPL-453 with Rifampin |
Primary outcome
AUC 0-t
Time frame: 25Days
Area under the plasma concentration - time curve from time 0 to time of last measurable concentration
AUC 0- ∞
Time frame: 25Days
Area under the plasma concentration - time curve from time 0 extrapolated to infinity
C max
Time frame: 25Days
Peak concentration
2 secondary outcomes
T max, t 1/2
Time frame: 25Days
AE rate
Time frame: through study completion, an average of 33days
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 13 Jul 2026.
- 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 HMPL-453 with Itraconazole and HMPL-453 with Rifampin in people with Health, Subjective, run by Hutchmed 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 23 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 13 Jul 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?
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?
AUC 0-t (time frame: 25Days). 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 13 Jul 2026.