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

NCT07876596 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-8080-106
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Peak concentration (Cmax)

  Primary PK parameters of HRS-8080.

  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.

  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.

  Day 1 to Day 15.

Secondary Outcomes (5)

• Time to Maximum Concentration (Tmax)

  Day 1 to Day 15.

• Elimination Half-Life (t1/2)

  Day 1 to Day 15.

• Apparent Oral Clearance (CL/F)

  Day 1 to Day 15.

• Apparent Volume of Distribution (Vz/F)

  Day 1 to Day 15.

• The incidence and severity of adverse events (AEs)

  Day 1 to Day 22.

Study Arms (1)

HRS-8080 and Rifampicin group

EXPERIMENTAL

HRS-8080, oral; Rifampicin, oral.

Drug: HRS-8080; Drug: Rifampicin

Interventions

HRS-8080 DRUG

HRS-8080, oral.

HRS-8080 and Rifampicin group

Rifampicin DRUG

Rifampicin, oral.

HRS-8080 and Rifampicin group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Rifampin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Central Study Contacts

Hongxiu Wang

CONTACT

+86-0518-82342973; hongxiu.wang.hw391@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

CN (1)