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Not yet recruitingNCT07876596Updated Oct 15, 2026

A Drug-Drug Interaction Study of Rifampicin and Oral HRS-8080

A Phase 1 interventional study of HRS-8080 and Rifampicin in Breast Cancer, sponsored by Shandong Suncadia Medicine Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Shandong Suncadia Medicine Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 18 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 87 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed informed consent before the trial; fully understood the trial content, procedures, and possible adverse reactions; able to complete the study per protocol.
  2. Healthy participants aged 18-55 years (inclusive) at the time of signing informed consent.
  3. At screening, male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, and BMI 19.0-28.0 kg/m² (inclusive).
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. Any clinically significant or interfering disease involving the cardiovascular, endocrine, nervous, digestive, respiratory, urogenital, hematologic, immunologic, psychiatric, or metabolic systems.
  2. Surgery within 6 months before screening, planned surgery during the study, or prior surgery affecting gastrointestinal absorption (e.g., gastrectomy, enterectomy, bariatric surgery).
  3. Blood donation or major blood loss (≥ 400 mL), transfusion, or use of blood products within 3 months before screening.
  4. Allergic constitution, including severe drug allergy or drug hypersensitivity; history of allergy to HRS-8080, rifampicin, rifamycin, or their excipients.
  5. Frequent use of sedatives, hypnotics, or other addictive drugs; history of drug abuse within 1 year before screening; positive urine drug abuse screen.
  6. 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.
  7. Participation in any clinical trial with an investigational drug within 3 months before first dosing.
  8. Use of any drug altering hepatic enzyme activity within 28 days before dosing.
  9. 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.
  10. Smoking > 5 cigarettes/day within 3 months before screening and unable to stop tobacco use during the study.
  11. 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.
  12. 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.
  13. Any positive result for HBsAg, anti-HCV, anti-TP, or anti-HIV.
  14. 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.
  15. 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.
  16. Intake of grapefruit-containing beverages or foods within 7 days before first dosing until study withdrawal and unwilling to stop.
  17. Special dietary requirements or inability to comply with a standardized diet.
  18. Live/attenuated vaccine within 3 months before first dosing, or planned live/attenuated/inactivated vaccine during the study (until last follow-up).
  19. Dysphagia.
  20. History of needle or blood phobia, poor venous access, difficult blood collection, or intolerance to venipuncture.
  21. Female participants who are pregnant or lactating.
  22. Any other condition deemed unsuitable for study participation by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    HRS-8080 and Rifampicin group

    HRS-8080, oral; Rifampicin, oral.

    Drug: HRS-8080 · Drug: Rifampicin

Interventions

06

What researchers measure

Primary outcomes

  1. Peak concentration (Cmax)

    Primary PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

  2. Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-t)

    Primary PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

  3. Area under the serum concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

    Primary PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

Secondary outcomes

  1. Time to Maximum Concentration (Tmax)

    Other PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

  2. Elimination Half-Life (t1/2)

    Other PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

  3. Apparent Oral Clearance (CL/F)

    Other PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

  4. Apparent Volume of Distribution (Vz/F)

    Other PK parameters of HRS-8080.

    Time frame: Day 1 to Day 15.

  5. The incidence and severity of adverse events (AEs)

    Safety and tolerability as assessed by the incidence and severity of AEs.

    Time frame: Day 1 to Day 22.

07

Study locations

1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510120, China
    • Junyan Wu · Contact · 13926018606@139.com · +86-020-34070717
    • Junyan Wu · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.

Of 306 industry-sponsored phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 57. This study's planned 3 months is below that.

Counting every sponsor, half of 645 studies reached it within 45 months; a quarter within 25 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 15, 2026
StartEst.
Nov 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07876596
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Nov 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Oct 15, 2026

Study contacts

Hongxiu Wang
Contact
hongxiu.wang.hw391@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: HRS-8080 · Rifampin

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