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 range18 Years – 45 Years
SexALL
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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.);
✕
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
8
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);