Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAdvenchen Laboratories Nanjing Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • AL3818 Capsule

    Drug

    dosage form: capsule; strength: 8 mg; orally in fasted condition

  • Itraconazole capsule

    Drug

    dosage form: capsule; strength: 0.1 g. Oral

  • Ticagrelor Tablets

    Drug

    dosage form: tablet; strength: 90 mg.Oral

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and TicagrelorExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

PK parameters of AL3818 include

Cmax

Time frame
through study completion, an average of 1 year
2

PK parameters of AL3818 include

AUC0-t

Time frame
through study completion, an average of 1 year
3

PK parameters of AL3818 include

AUC0-∞

Time frame
through study completion, an average of 1 year
4

PK parameters of AL3818 include

Tmax

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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