Actively Recruiting
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet
Led by Guangzhou Lupeng Pharmaceutical Company LTD. · Updated on 2026-03-09
28
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects.
CONDITIONS
Official Title
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 45 years inclusive and male or female at time of consent
- No history of serious diseases affecting digestive, nervous, cardiovascular, genitourinary, respiratory, metabolic, musculoskeletal, hematologic systems or tumors
- Males weigh at least 50.0 kg; females weigh at least 45.0 kg
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m² inclusive
- Agree to complete abstinence or use effective physical contraception from consent until 90 days after last dose
- Understand and comply with study requirements
- Voluntarily agree to participate and sign informed consent form
You will not qualify if you...
- Clinically significant abnormalities in vital signs, physical exam, or lab tests
- Clinically significant abnormal electrocardiogram or myocardial enzymes (e.g., QTcF ≥ 450 ms)
- Positive tests for hepatitis B surface antigen, hepatitis C virus antibody, HIV antibody, or syphilis antibody
- Use of investigational drugs within 4 weeks prior to study or drugs altering liver enzyme activity during study
- Use of systemic medications, vaccines, or supplements within 2 weeks before investigational drug
- Consumption of foods affecting liver enzymes or tobacco within 1 week before investigational drug
- Consumption of caffeine, tea, alcohol, or xanthine within 24 hours before investigational drug
- Difficulty swallowing or conditions affecting drug absorption, metabolism, or excretion
- Positive pregnancy test or breastfeeding women
- History of smoking more than 5 cigarettes/day within 3 months or positive nicotine screen
- History of alcohol abuse or positive alcohol breath test
- History of drug abuse or positive drug abuse screen
- Known allergies requiring medication or allergic diseases
- Blood donation or loss of ≥400 ml blood within 3 months before screening, or plans to donate during study and 3 months after
- Surgery within past 6 months or planned surgery/hospitalization during study
- Participation in other drug or device trials within 3 months prior or planned during study
- Special dietary requirements or inability to comply with dietary rules during hospitalization
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
D
Dongyang Prof. Liu, PhD
CONTACT
F
Fangfang Dr. Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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