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

A Non-Randomized, Open-Label Clinical Study of Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) With Itraconazole and Ticagrelor in Healthy Volunteer Subjects

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: AL3818 Capsule; Drug: Itraconazole capsule; Drug: Ticagrelor Tablets

Detailed Description

This is a non-randomized, open-label, single-center, fixed-sequence drug-drug interaction (DDI) study to evaluate the effects of itraconazole and ticagrelor on the pharmacokinetics of catequentinib hydrochloride (AL3818) in healthy adult subjects. Eligible subjects will receive a single dose of AL3818 alone and in combination with multiple doses of itraconazole or ticagrelor in different periods. Serial blood samples will be collected to determine plasma concentrations of AL3818. Safety and tolerability will be monitored throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qing He; Phone Number: 13358112136; Email: heq@gobroadhealthcare.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102200
      • Beijing GoBroad Hospital Ethics Review Committee
      • Contact: Xiaohua Tian; Phone Number: 010-50847588 extension 682; Email: bjgbll@gobroadhealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

A subject is eligible for enrollment in the study only if all of the following criteria are met:

1. Male or female; aged between 18 and 45 years old (inclusive).
2. 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).
3. 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.
4. The subject voluntarily signed a written informed consent form and is able to communicate well with the investigator.

Exclusion Criteria:

Subjects who meet any of the following criteria before screening will be excluded from the study:

1. 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;
2. History of dysphagia or any gastrointestinal diseases affecting drug absorption, digestive system diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months;
3. 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.);
4. Subjects who have had clinically significant major diseases or major surgical procedures within 3 months prior to;
5. 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;
6. Participation in any clinical trial as a subject within 3 months;
7. Subjects with drug abuse history within 5 years or drug use within 3 months or positive urine drug abuse screening at baseline;
8. Anyone who has taken any prescription, over-the-counter, vitamin or herbal medicine within 2 weeks or 5 half-lives (whichever is longer);
9. Any drug known to be an inhibitor or inducer of CYP3A4 enzymes or a sensitive substrate (Appendix 4), any drug known to be a P-gp inhibitor or substrate (Appendix 5), any drug known to be a BCRP inhibitor or substrate (Appendix 6), or any drug known to cause a risk of torsades de pointes (TdP) (Appendix 7) within 4 weeks;
10. Vaccination within 3 months or planned during this trial;
11. Subjects with a history of bleeding and needle phobia, unable to tolerate intravenous indwelling needle injection;
12. Subjects with neurological/psychiatric, respiratory, cardiovascular, digestive tract, blood and lymphatic system, endocrine, musculoskeletal disorders, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the study results at screening;
13. Screening or baseline 12-lead ECG with QTcF interval ≥ 450 ms (males), QTcF interval ≥ 460 ms (females); or ECG abnormal and considered abnormal and clinically significant by the investigator;

14. Laboratory test results during screening period or baseline period meet the following abnormal range requirements and are considered abnormal and clinically significant by the investigator:

    1. Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ULN;
    2. Abnormal coagulation function: activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≥ULN;
    3. Abnormal thyroid function: Free triiodothyronine (FT3) or free thyroxine (FT4) or thyroid stimulating hormone (TSH) higher than ULN;
15. Subjects with hepatitis B surface antigen quantitative determination positive, hepatitis C antibody quantitative determination positive, human immunodeficiency virus antigen antibody determination positive or treponema pallidum antibody determination positive at screening period or baseline period;
16. Have special requirements for diet and fail to comply with the diet and corresponding regulations provided by the clinical trial institution;
17. Those who cannot control special diet (including pitaya, mango, grapefruit and/or xanthine diet, caffeine-containing food or beverage, etc.) during the trial;
18. Strenuous exercise within 48 hours prior to the first dose, or planned strenuous exercise during the trial;
19. Regular drinkers within 6 months or during the trial, i.e. drinking more than 21 units of alcohol (male) or 14 units of alcohol (female) per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or unable to stop drinking during the trial, or positive alcohol breath test at baseline;
20. Smoking more than 5 cigarettes per day in the 3 months, or using any tobacco products during the trial;
21. Pregnant or lactating women or those with positive blood pregnancy test results;
22. Subjects who have used long-acting estrogen or progesterone injection or implant tablets within 6 months or during the trial;
23. Women of childbearing age who have had unprotected sex with their partners within 14 days prior to screening;
24. Male or female subjects of childbearing potential do not agree to use an effective method of contraception from the time of signing informed consent until 6 months after the last dose (see Section 10.3 for details of specific methods of contraception);
25. Sperm or egg donation or fertility planning within 6 months from signing the informed consent form to the last dose;
26. Vulnerable subjects such as the investigator himself/herself, relevant personnel of the study site and their family members, students and subordinates of the investigator, and employees of the sponsor;
27. Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor; Subjects will take AL3818 8 mg orally in fasted condition on D1, D29 and D58 together with itraconazole or ticagrelor for a convenience. Subjects are prohibited from eating and drinking for 4 h before dosing and for 4h after dosing. Water is prohibited from 1 h before dosing to 1 h after dosing, except for water administered to subjects. Meal may be eaten 4 hours after dosing and subjects should be dosed at approximately the same time as eating each day. Subjects will take itraconazole capsule 400 mg orally in D26 and take itraconazole capsule 200mg QD orally from D27 to D39 for 14 consecutive days at approximately the same time each day. Subjects will take ticagrelor tablet 90 mg orally twice daily, once in the morning and once in the evening for 4 consecutive days from D57 to D60.

Drug: AL3818 Capsule; dosage form: capsule; strength: 8 mg; orally in fasted condition; Drug: Itraconazole capsule; dosage form: capsule; strength: 0.1 g. Oral; Drug: Ticagrelor Tablets; dosage form: tablet; strength: 90 mg.Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of AL3818 include	Cmax	through study completion, an average of 1 year
PK parameters of AL3818 include	AUC0-t	through study completion, an average of 1 year
PK parameters of AL3818 include	AUC0-∞	through study completion, an average of 1 year
PK parameters of AL3818 include	Tmax	through study completion, an average of 1 year
PK parameters of AL3818 include	λz	through study completion, an average of 1 year
PK parameters of AL3818 include	t1/2z	through study completion, an average of 1 year
PK parameters of AL3818 include	Vz/F	through study completion, an average of 1 year
PK parameters of AL3818 include	CL/F	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Advenchen Laboratories Nanjing Ltd.
• Investigators: Principal Investigator: Qing He, Beijing GoBroad Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Nucleosides; Ribonucleosides; Triazoles; Adenosine; Purine Nucleosides; Piperazines; Ticagrelor; Itraconazole; anlotinib
• Other Study ID Numbers: AL3818-US-004-DDI-HV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No