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

NCT07438886 | Not Yet Recruiting Phase 1

• 1 other identifier: AL3818-US-004-DDI-HV
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor

EXPERIMENTAL

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; Drug: Itraconazole capsule; Drug: Ticagrelor Tablets

Interventions

AL3818 Capsule DRUG

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

Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor

Itraconazole capsule DRUG

dosage form: capsule; strength: 0.1 g. Oral

Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor

Ticagrelor Tablets DRUG

dosage form: tablet; strength: 90 mg.Oral

Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Subjects who meet any of the following criteria before screening will be excluded from the study:
• 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;
• 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);
• 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;
• Vaccination within 3 months or planned during this trial;
• Subjects with a history of bleeding and needle phobia, unable to tolerate intravenous indwelling needle injection;
• 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;
• 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;
• 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:

Sponsors & Collaborators

• Advenchen Laboratories Nanjing Ltd.: lead

Study Sites (1)

Beijing GoBroad Hospital Ethics Review Committee

Beijing, Beijing Municipality, 102200, China

Location

MeSH Terms

Interventions

anlotinib; Itraconazole; Ticagrelor

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Qing He

  Beijing GoBroad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing He

CONTACT

13358112136; heq@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)