Healthy volunteers needed to test new drug interactions
NCT ID NCT07374224
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study looks at how two common drugs—itraconazole (a fungus treatment) and rifampin (an antibiotic)—change the way the body processes rocbrutinib, an experimental medicine. About 28 healthy adults will take rocbrutinib alone and then with each other drug to measure blood levels and safety. The goal is to gather information, not to treat any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects had no history of serious digestive system (such as inflammatory bowel disease, chronic diarrhea, Crohn's disease, autonomic dysfunction affecting gastric emptying), nervous system, cardiovascular system, genitourinary system, respiratory system, metabolic and endocrine system, musculoskeletal system, hematologic system diseases, or tumors * Subjects must agree to complete abstinence or use effective physical contraception (including sterilization, intrauterine device or barrier contraception) from the time of signing the informed consent form until 90 days after the last dose of medication, and have no plans to donate sperm or eggs during this period; if female subjects are using hormonal contraceptives, they must stop using them \>14 days before the first dose and use at least one of the above contraceptive methods. * Must be between 18 and 45 years old (inclusive) and be male or female when signing the informed consent form. * Males weighing ≥50.0 kg or females weighing ≥45.0 kg, with a Body Mass Index (BMI) between 18.0 and 28.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²). * Able to understand and comply with the requirements of the research plan. * Voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Abnormalities in screening tests, such as vital signs, physical examination, or laboratory tests are clinically significant and may increase the risk of participants participating in the study or affect the scientific validity of the study. * Abnormal electrocardiogram or myocardial enzyme levels that are clinically significant as determined by a clinician include, but are not limited to: QTcF ≥ 450 ms (corrected using the Fridricia formula, QTcF = QT/RR1/3, RR = 60/HR), etc. * The test results for at least one of the following are positive: hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and syphilis-specific antibody. * Patients who have taken the investigational drug within 4 weeks prior to or are required to take any drugs known to alter liver enzyme activity during the study period. * The patient must have used any systemic medications (including any vaccines, prescription drugs, over-the-counter drugs, and traditional Chinese medicines), special medical purpose foods, or health supplements within two weeks prior to taking the investigational drug. * Had consumed foods known to alter liver enzyme activity (such as grapefruit, star fruit, dragon fruit, and their fruit juices) and tobacco (including e-cigarettes) within one week prior to taking the investigational drug. * Consume any food or beverage containing caffeine, tea, alcohol, or xanthine within 24 hours prior to taking the investigational drug. * Difficulty swallowing or any condition that affects drug absorption, distribution, metabolism, or excretion. * Women with childbearing potential who have a positive pregnancy test result or who are currently breastfeeding. * Those with a history of smoking (smoking more than 5 cigarettes/day within 3 months prior to screening) or who tested positive for nicotine screening. * Those with a history of alcohol abuse (consuming more than 14 drinks per week, each drink equivalent to 360 ml of beer, 150 ml of wine, or 50 ml of spirits), or those who test positive for alcohol in a breathalyzer test. * Those with a history of drug abuse/use, or who test positive in drug abuse screening. * Those with a known history of any allergic reaction requiring medication (including allergic reactions to drugs or food) or who have an allergic disease. * Individuals who have donated blood or lost ≥400 ml of blood within the three months prior to screening, or those who plan to donate blood during the study period and within three months after its completion, will be considered. * Those who have undergone surgery within the past 6 months or are expected to require surgery or hospitalization during the study period will be screened. * Candidates who have participated in other drug or medical device clinical trials within the three months prior to screening, or who plan to participate in other drug or medical device clinical trials during the study period, are eligible to be screened. * Subjects with special dietary requirements or who are expected to be unable to comply with the research center's dietary requirements during their hospitalization * The researchers believe that there are other circumstances that make the participants unsuitable to participate in this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, 100070, China