Breast CancerPhase 1NCT07876596
A Drug-Drug Interaction Study of Rifampicin and Oral HRS-8080
A Phase 1 study testing HRS-8080 and Rifampicin in people with Breast Cancer, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
A single-center, single-arm, open-label, fixed-sequence study is planned to enroll 18 healthy participants (6-9 females). The study consists of a screening period, an observation period, and a safety follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-8080 and Rifampicin
- 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 Feb 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent before the trial; fully understood the trial content, procedures, and possible adverse reactions; able to complete the study per protocol.
- Healthy participants aged 18-55 years (inclusive) at the time of signing informed consent.
- At screening, male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, and BMI 19.0-28.0 kg/m² (inclusive).
- Healthy participants confirmed by the investigator at screening and baseline to have no clinically significant abnormalities, including medical history, general physical examination, vital signs, laboratory tests (blood routine, urinalysis, blood biochemistry, and coagulation function), and ECG.
- Participants of childbearing potential (including partners) agreed to have no plans for pregnancy or sperm/egg donation from informed consent until 3 months after the last dose, and voluntarily used highly effective contraception (including partners); female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must be non-lactating.
Who cannot join
- Any clinically significant or interfering disease involving the cardiovascular, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, psychiatric, or metabolic systems.
- Surgery within 6 months before screening, planned surgery during the study, or prior surgery affecting gastrointestinal absorption (e.g., gastrectomy, enterectomy, bariatric surgery).
- Blood donation or major blood loss (≥ 400 mL), transfusion, or use of blood products within 3 months before screening.
- Allergic constitution, including severe drug allergy or drug hypersensitivity; history of allergy to HRS-8080, rifampicin, rifamycin, or their excipients.
- Frequent use of sedatives, hypnotics, or other addictive drugs; history of drug abuse within 1 year before screening; positive urine drug abuse screen.
- Use of hepatotoxic drugs (e.g., isoniazid, pyrazinamide, methotrexate, leflunomide, valproate, amiodarone, acetaminophen, dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for > 7 consecutive days within 2 months before screening.
Show all 22Show fewer
- Participation in any clinical trial with an investigational drug within 3 months before first dosing.
- Use of any drug altering hepatic enzyme activity within 28 days before dosing.
- Use of any prescription drug or herbal medicine within 1 month, or any OTC drug or food supplement (including vitamins, calcium tablets) within 2 weeks before first dosing.
- Smoking > 5 cigarettes/day within 3 months before screening and unable to stop tobacco use during the study.
- Frequent alcohol use within 6 months before screening (> 14 units/week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine) and unable to stop alcohol during the study; positive alcohol breath test.
- Clinically significant abnormalities in vital signs, physical examination, 12-lead ECG, abdominal ultrasound, chest X-ray, blood routine, blood biochemistry, urinalysis, or coagulation at screening.
- Any positive result for HBsAg, anti-HCV, anti-TP, or anti-HIV.
- Intake of > 8 servings (1 serving = 250 mL) of caffeine-containing beverages or equivalent within 48h before first dosing and unable to abstain during the study.
- Intake of methylxanthine-containing beverages or foods (e.g., coffee, tea, cola, chocolate) within 48h before first dosing until study withdrawal and unwilling to stop.
- Intake of grapefruit-containing beverages or foods within 7 days before first dosing until study withdrawal and unwilling to stop.
- Special dietary requirements or inability to comply with a standardized diet.
- Live/attenuated vaccine within 3 months before first dosing, or planned live/attenuated/inactivated vaccine during the study (until last follow-up).
- Dysphagia.
- History of needle or blood phobia, poor venous access, difficult blood collection, or intolerance to venipuncture.
- Female participants who are pregnant or lactating.
- Any other condition deemed unsuitable for study participation by the investigator.
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
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Junyan Wu, +86-020-34070717, 13926018606@139.com
Junyan Wu
About this study
Official title: A Single-center, Single-arm, Open-label, Fixed-sequence Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Oral HRS-8080 in Healthy Participants
A single-center, single-arm, open-label, fixed-sequence study is planned to enroll 18 healthy participants (6-9 females). The study consists of a screening period, an observation period, and a safety follow-up period.
- Conditions
- Breast Cancer
- Being tested
- HRS-8080, Rifampicin
- 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-8080Drug
HRS-8080, oral.
RifampicinDrug
Rifampicin, oral.
| Study group | Role | What they receive |
|---|---|---|
| HRS-8080 and Rifampicin group | Experimental | HRS-8080, oral; Rifampicin, oral. Receives: Drug: HRS-8080; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Primary PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)
Primary PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Primary PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
Secondary outcomes (5)
Time to Maximum Concentration (Tmax)
Other PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
Elimination Half-Life (t1/2)
Other PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
Apparent Oral Clearance (CL/F)
Other PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
Apparent Volume of Distribution (Vz/F)
Other PK parameters of HRS-8080.
Measured: Day 1 to Day 15.
The incidence and severity of adverse events (AEs)
Safety and tolerability as assessed by the incidence and severity of AEs.
Measured: Day 1 to Day 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (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 Shandong Suncadia 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center, single-arm, open-label, fixed-sequence design will be used, with a planned enrollment of 18 healthy participants, including 6-9 female participants.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876596
- Sponsor's protocol ID
- HRS-8080-106
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 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 15 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 Rifampin on the Pharmacokinetics of Oral HRS-8080 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07876596
- Acronym / sponsor ID
- HRS-8080-106
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 15 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.
A single-center, single-arm, open-label, fixed-sequence study is planned to enroll 18 healthy participants (6-9 females). The study consists of a screening period, an observation period, and a safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center, single-arm, open-label, fixed-sequence design will be used, with a planned enrollment of 18 healthy participants, including 6-9 female participants.
| Arm | Type | Receives |
|---|---|---|
| HRS-8080 and Rifampicin group | Experimental | Drug: HRS-8080, Drug: RifampicinHRS-8080, oral; Rifampicin, oral. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent before the trial; fully understood the trial content, procedures, and possible adverse reactions; able to complete the study per protocol.
- Healthy participants aged 18-55 years (inclusive) at the time of signing informed consent.
- At screening, male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, and BMI 19.0-28.0 kg/m² (inclusive).
- Healthy participants confirmed by the investigator at screening and baseline to have no clinically significant abnormalities, including medical history, general physical examination, vital signs, laboratory tests (blood routine, urinalysis, blood biochemistry, and coagulation function), and ECG.
- Participants of childbearing potential (including partners) agreed to have no plans for pregnancy or sperm/egg donation from informed consent until 3 months after the last dose, and voluntarily used highly effective contraception (including partners); female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and must be non-lactating.
Key exclusion criteria (22 listed)
- Any clinically significant or interfering disease involving the cardiovascular, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, psychiatric, or metabolic systems.
- Surgery within 6 months before screening, planned surgery during the study, or prior surgery affecting gastrointestinal absorption (e.g., gastrectomy, enterectomy, bariatric surgery).
- Blood donation or major blood loss (≥ 400 mL), transfusion, or use of blood products within 3 months before screening.
- Allergic constitution, including severe drug allergy or drug hypersensitivity; history of allergy to HRS-8080, rifampicin, rifamycin, or their excipients.
- Frequent use of sedatives, hypnotics, or other addictive drugs; history of drug abuse within 1 year before screening; positive urine drug abuse screen.
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-8080HRS-8080, oral. | Drug | HRS-8080 and Rifampicin group |
| RifampicinRifampicin, oral. | Drug | HRS-8080 and Rifampicin group |
Primary outcome
Peak concentration (Cmax)
Time frame: Day 1 to Day 15.
Primary PK parameters of HRS-8080.
Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)
Time frame: Day 1 to Day 15.
Primary PK parameters of HRS-8080.
Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Day 1 to Day 15.
Primary PK parameters of HRS-8080.
5 secondary outcomes
Time to Maximum Concentration (Tmax)
Time frame: Day 1 to Day 15.
Elimination Half-Life (t1/2)
Time frame: Day 1 to Day 15.
Apparent Oral Clearance (CL/F)
Time frame: Day 1 to Day 15.
Apparent Volume of Distribution (Vz/F)
Time frame: Day 1 to Day 15.
The incidence and severity of adverse events (AEs)
Time frame: Day 1 to Day 22.
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 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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 HRS-8080 and Rifampicin in people with Breast Cancer, run by Shandong Suncadia 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 5 inclusion and 22 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 15 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 Hongxiu Wang (+86-0518-82342973, hongxiu.wang.hw391@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration (Cmax) (time frame: Day 1 to Day 15.). 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 15 Oct 2026.