Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers (NCT07438886) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers
China16 participantsStarted 2026-03-02
Plain-language summary
This is a non-randomized, open-label, fixed-sequence drug-drug interaction study to evaluate the effects of itraconazole and ticagrelor on the pharmacokinetics of catequentinib hydrochloride (AL3818) in healthy volunteers.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female; aged between 18 and 45 years old (inclusive).
. Male subjects weight ≥50 kg, female subjects weight ≥45 kg, body mass index (BMI) between 19.0 and 26.0 kg/m2 , BMI= weight (kg)/height2 (m2 ) (inclusive).
. Physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, urine routine, blood biochemistry, blood lipid, coagulation function and thyroid function, etc.) and chest X-ray at screening showed no clinically significant abnormalities, and the clinical study doctor judged them qualified.
. The subject voluntarily signed a written informed consent form and is able to communicate well with the investigator.
Exclusion criteria
. History of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory, endocrine, immune, blood and lymphatic, skeletal/muscular, nervous and other system diseases), history of liver and kidney insufficiency, history of mental diseases, history of drug dependence, bleeding tendency (such as recent trauma, recent surgery, coagulation dysfunction, active or recent gastrointestinal bleeding), history of active pathological bleeding, history of intracranial hemorrhage, family history of hypertension;
. History of dysphagia or any gastrointestinal diseases affecting drug absorption, digestive system diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months;
. Allergic to any component of the investigational product (AL3818, itraconazole capsule, ticagrelor tablet) and its excipients, with a history of drug or food allergy, or history of specific allergy (asthma, urticaria, eczema, etc.);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
2
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
3
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
4
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
5
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
6
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
7
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year
. Subjects who have had clinically significant major diseases or major surgical procedures within 3 months prior to;
. Subjects who donated blood within 3 months, or planned to donate blood within the study period, or Subjects who had blood transfusion or blood loss ≥200 mL within 4 weeks;
. Participation in any clinical trial as a subject within 3 months;
. Subjects with drug abuse history within 5 years or drug use within 3 months or positive urine drug abuse screening at baseline;
. Anyone who has taken any prescription, over-the-counter, vitamin or herbal medicine within 2 weeks or 5 half-lives (whichever is longer);
PK parameters of AL3818 include
Timeframe: through study completion, an average of 1 year