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Healthy volunteers needed to test drug interactions for cancer drug candidate

NCT ID NCT07438886

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study looks at how two common drugs—itraconazole (an antifungal) and ticagrelor (a blood thinner)—change the way the body processes AL3818, a potential cancer treatment. Sixteen healthy adults aged 18 to 45 will take AL3818 alone and then with each other drug. The goal is to measure drug levels in the blood, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
catequentinib hydrochloride (AL3818)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing GoBroad Hospital Ethics Review Committee

    Beijing, Beijing Municipality, 102200, China

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