Breast CancerPhase 1NCT07610148
A Study to Estimate Effect of Formulation and Food on Relative Bioavailability of HRS-6209 in Healthy Participants
A Phase 1 study testing HRS-6209 Capsule (old formulation) and HRS-6209 Capsule (new formulation) in people with Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-6209 Capsule (old formulation) and HRS-6209 Capsule (new formulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged 18 to 50 years old at informed consent signing.
- Male body weight ≥ 50 kg, female ≥ 45 kg; BMI 19 to 26 kg/m² at screening and baseline.
- Have no clinically significant abnormalities at screening and baseline.
- Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 6 months after the last dose (abstinence or highly effective contraception); no sperm/egg donation.
Who cannot join
- Current or history of clinically significant disorders of any major system (urinary, circulatory, endocrine, nervous, digestive, respiratory, hematologic, immune, psychiatric, metabolic, etc.) or any other condition that may interfere with study results per investigator judgment.
- History of epilepsy, including febrile seizures in childhood, loss of consciousness, transient ischemic attack, or any condition predisposing to seizures (e.g., cerebrovascular disease, brain injury, stroke, brain cancer).
- Clinically significant acute illness within 1 month prior to screening, including fever or febrile symptoms, viral, bacterial (including upper respiratory tract infection), or non-cutaneous fungal infections.
- Any surgery within 6 months prior to study, or planned surgery during study period; prior surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, bariatric surgery) or affecting liver function.
- Positive for anti-HCV, anti-HIV, HBsAg, or syphilis antibodies.
- Blood donation or loss ≥ 400 mL within 3 months, or ≥ 200 mL within 1 month prior to screening; blood transfusion or use of blood products within 3 months prior to screening.
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- Long-term use (> 7 consecutive days) of hepatotoxic drugs within 6 months; use of any drug affecting liver metabolism within 1 month prior to first dose; use of other drugs (prescription, OTC, herbal, vitamins, calcium, etc.) within 14 days prior to first dose, other than those affecting liver metabolism.
- Participation in another clinical trial with investigational drug within 3 months; vaccination within 3 months prior to screening or planned during study.
- History of drug abuse/dependence; positive urine drug screen at screening.
- History of heavy smoking (average ≥ 5 cigarettes/day) within 3 months prior to screening; inability to abstain from any tobacco products during study; positive smoke screen.
- Alcoholism (average daily intake exceeding: > 14 units/week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine); positive alcohol screen; inability to abstain from alcohol during study.
- Special dietary requirements or inability to comply with standardized meals.
- Dysphagia, difficulty with venous blood collection, or inability to tolerate intensive blood sampling.
- Other conditions that, in the investigator's judgment, make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, 350001
About this study
Official title: A Single-Center, Single-Dose, Randomized, Open-Label, Three-Period, Three-Sequence, Crossover Study to Evaluate the Oral Relative Bioavailability of Old and New Formulations of HRS-6209 Capsules and the Effect of Food in Healthy Chinese Participants
This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. A total of 21 healthy participants will be randomised to receive a single oral dose of HRS-6209 in three treatment periods: old formulation (fasted); new formulation (fasted); new formulation (fasted).
- Conditions
- Breast Cancer
- Being tested
- HRS-6209 Capsule (old formulation), HRS-6209 Capsule (new formulation)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6209 Capsule (old formulation)Drug
Oral administration after fasting.
HRS-6209 Capsule (new formulation)Drug
Oral administration after fasting/high-fat meal.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving treatment sequence A+C+B | Experimental | Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. Receives: Drug: HRS-6209 Capsule (old formulation); Drug: HRS-6209 Capsule (new formulation) |
| Participants receiving treatment sequence C+B+A | Experimental | Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. Receives: Drug: HRS-6209 Capsule (old formulation); Drug: HRS-6209 Capsule (new formulation) |
| Participants receiving treatment sequence B+A+C | Experimental | Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. Receives: Drug: HRS-6209 Capsule (old formulation); Drug: HRS-6209 Capsule (new formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve (AUC)
pharmacokinetics (PK) parameter of HRS-6209.
Measured: Day 1 - Day 9.
Maximum Plasma Concentration (Cmax)
pharmacokinetics (PK) parameter of HRS-6209.
Measured: Day 1 - Day 9.
Secondary outcomes (1)
Incidence and severity of adverse events / serious adverse events (AEs / SAEs)
Safety assessment, graded as per CTCAE 6.0.
Measured: Up to 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start8 Jun 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an open-label, randomized, 3-way, 3-period crossover study.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610148
- Sponsor's protocol ID
- HRS-6209-102
- Status last verified
- Aug 2026
- First submitted
- 20 May 2026
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Dose, Randomized, Open-Label, Three-Period, Three-Sequence, Crossover Study to Evaluate the Oral Relative Bioavailability of Old and New Formulations of HRS-6209 Capsules and the Effect of Food in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07610148
- Acronym / sponsor ID
- HRS-6209-102
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 May 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, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. A total of 21 healthy participants will be randomised to receive a single oral dose of HRS-6209 in three treatment periods: old formulation (fasted); new formulation (fasted); new formulation (fasted).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is an open-label, randomized, 3-way, 3-period crossover study.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving treatment sequence A+C+B | Experimental | Drug: HRS-6209 Capsule (old formulation), Drug: HRS-6209 Capsule (new formulation)Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. |
| Participants receiving treatment sequence C+B+A | Experimental | Drug: HRS-6209 Capsule (old formulation), Drug: HRS-6209 Capsule (new formulation)Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. |
| Participants receiving treatment sequence B+A+C | Experimental | Drug: HRS-6209 Capsule (old formulation), Drug: HRS-6209 Capsule (new formulation)Treatment sequence A = HRS-6209 capsule old formulation given in fasted state; Treatment sequence B = HRS-6209 capsule new formulation given in fasted state; Treatment sequence C = HRS-6209 capsule new formulation given in fed state. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 18 to 50 years old at informed consent signing.
- Male body weight ≥ 50 kg, female ≥ 45 kg; BMI 19 to 26 kg/m² at screening and baseline.
- Have no clinically significant abnormalities at screening and baseline.
- Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 6 months after the last dose (abstinence or highly effective contraception); no sperm/egg donation.
Key exclusion criteria (14 listed)
- Current or history of clinically significant disorders of any major system (urinary, circulatory, endocrine, nervous, digestive, respiratory, hematologic, immune, psychiatric, metabolic, etc.) or any other condition that may interfere with study results per investigator judgment.
- History of epilepsy, including febrile seizures in childhood, loss of consciousness, transient ischemic attack, or any condition predisposing to seizures (e.g., cerebrovascular disease, brain injury, stroke, brain cancer).
- Clinically significant acute illness within 1 month prior to screening, including fever or febrile symptoms, viral, bacterial (including upper respiratory tract infection), or non-cutaneous fungal infections.
- Any surgery within 6 months prior to study, or planned surgery during study period; prior surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, bariatric surgery) or affecting liver function.
- Positive for anti-HCV, anti-HIV, HBsAg, or syphilis antibodies.
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-6209 Capsule (old formulation)Oral administration after fasting. | Drug | Participants receiving treatment sequence A+C+B, Participants receiving treatment sequence B+A+C, Participants receiving treatment sequence C+B+A |
| HRS-6209 Capsule (new formulation)Oral administration after fasting/high-fat meal. | Drug | Participants receiving treatment sequence A+C+B, Participants receiving treatment sequence B+A+C, Participants receiving treatment sequence C+B+A |
Primary outcome
Area under the concentration time curve (AUC)
Time frame: Day 1 - Day 9.
pharmacokinetics (PK) parameter of HRS-6209.
Maximum Plasma Concentration (Cmax)
Time frame: Day 1 - Day 9.
pharmacokinetics (PK) parameter of HRS-6209.
1 secondary outcome
Incidence and severity of adverse events / serious adverse events (AEs / SAEs)
Time frame: Up to 1 month.
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 25 Aug 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. 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 HRS-6209 Capsule (old formulation) and HRS-6209 Capsule (new formulation) in people with Breast Cancer, run by Jiangsu HengRui Medicine 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 14 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 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?
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?
Area under the concentration time curve (AUC) (time frame: Day 1 - Day 9.). The study lists 2 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 25 Aug 2026.