Healthy VolunteerPhase 1NCT07438886
Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction Study in Healthy Volunteers
A Phase 1 study testing AL3818 Capsule, Itraconazole capsule and Ticagrelor Tablets in people with Healthy Volunteer, run by Advenchen Laboratories Nanjing Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- AL3818 Capsule, Itraconazole capsule and Ticagrelor Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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:
- Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≥ULN;
- Abnormal coagulation function: activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≥ULN;
- Abnormal thyroid function: Free triiodothyronine (FT3) or free thyroxine (FT4) or thyroid stimulating hormone (TSH) higher than ULN;
- 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;
- Have special requirements for diet and fail to comply with the diet and corresponding regulations provided by the clinical trial institution;
- Those who cannot control special diet (including pitaya, mango, grapefruit and/or xanthine diet, caffeine-containing food or beverage, etc.) during the trial;
- Strenuous exercise within 48 hours prior to the first dose, or planned strenuous exercise during the trial;
- 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;
- Smoking more than 5 cigarettes per day in the 3 months, or using any tobacco products during the trial;
- Pregnant or lactating women or those with positive blood pregnancy test results;
- Subjects who have used long-acting estrogen or progesterone injection or implant tablets within 6 months or during the trial;
- Women of childbearing age who have had unprotected sex with their partners within 14 days prior to screening;
- 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);
- Sperm or egg donation or fertility planning within 6 months from signing the informed consent form to the last dose;
- 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;
- Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing GoBroad Hospital Ethics Review Committee
Beijing, Beijing Municipality, 102200
Xiaohua Tian, 010-50847588 extension 682, bjgbll@gobroadhealthcare.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- AL3818 Capsule, Itraconazole capsule, Ticagrelor Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL3818 CapsuleDrug
dosage form: capsule; strength: 8 mg; orally in fasted condition
Itraconazole capsuleDrug
dosage form: capsule; strength: 0.1 g. Oral
Ticagrelor TabletsDrug
dosage form: tablet; strength: 90 mg.Oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AL3818 Capsule; Drug: Itraconazole capsule; Drug: Ticagrelor Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of AL3818 include
Cmax
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
AUC0-t
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
AUC0-∞
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
Tmax
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
λz
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
t1/2z
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
Vz/F
Measured: through study completion, an average of 1 year
PK parameters of AL3818 include
CL/F
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Mar 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing He, Principal investigator, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438886
- Sponsor's protocol ID
- AL3818-US-004-DDI-HV
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label Clinical Study of Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) With Itraconazole and Ticagrelor in Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT07438886
- Acronym / sponsor ID
- AL3818-US-004-DDI-HV
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor | Experimental | Drug: AL3818 Capsule, Drug: Itraconazole capsule, Drug: Ticagrelor TabletsSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (31 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL3818 Capsuledosage form: capsule; strength: 8 mg; orally in fasted condition | Drug | Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor |
| Itraconazole capsuledosage form: capsule; strength: 0.1 g. Oral | Drug | Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor |
| Ticagrelor Tabletsdosage form: tablet; strength: 90 mg.Oral | Drug | Catequentinib Hydrochloride (AL3818) Drug-Drug Interaction (DDI) with Itraconazole and Ticagrelor |
Primary outcome
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
Cmax
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
AUC0-t
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
AUC0-∞
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
Tmax
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
λz
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
t1/2z
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
Vz/F
PK parameters of AL3818 include
Time frame: through study completion, an average of 1 year
CL/F
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qing He principal investigator
Beijing GoBroad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AL3818 Capsule, Itraconazole capsule and Ticagrelor Tablets in people with Healthy Volunteer, run by Advenchen Laboratories Nanjing Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing He (13358112136, heq@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK parameters of AL3818 include (time frame: through study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.