About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.);
Subjects who have had clinically significant major diseases or major surgical procedures within 3 months prior to;
Trial design
Single group
Treatments tested in this trial
AL3818 Capsule
Drugdosage form: capsule; strength: 8 mg; orally in fasted condition
Itraconazole capsule
Drugdosage form: capsule; strength: 0.1 g. Oral
Ticagrelor Tablets
Drugdosage form: tablet; strength: 90 mg.Oral
Treatment groups
Trial outcomes
Primary outcomes
PK parameters of AL3818 include
Cmax
PK parameters of AL3818 include
AUC0-t
PK parameters of AL3818 include
AUC0-∞
PK parameters of AL3818 include
Tmax
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: