A Clinical Trial to Evaluate the Relative Bioavailability of New and Old ABSK-011 Capsules

Last updated: March 11, 2024
Sponsor: Abbisko Therapeutics Co, Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Sequence A ABSK-011

Sequence B ABSK-011

Clinical Study ID

NCT06306872
ABSK-011-102
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy subjects aged between 18 and 45 years (including 18 and 45 years) at the timeof screening;
  2. Male ≥50 kg, female ≥45kg, body mass index (BMI) between 19 and 28 (including 19 and 28), BMI= weight (kg)/height (m) 2;
  3. Physical examination, laboratory examination and other relevant examination resultsbefore the first medication are normal or abnormal but meet the followingrequirements, or other abnormal results but not clinically significant determined bythe investigator:
  4. 35.9℃≤ ear temperature ≤37.5℃;
  5. pulse rate ≥55 times/min and ≤100 times/min;
  6. Systolic blood pressure ≥90 mmHg and < 140 mmHg, diastolic blood pressure ≥60mmHgand < 90 mmHg;
  7. Total bilirubin (TBIL) ≤1.5×ULN;
  8. Fertile male or female subjects must consent to the use of an effective contraceptivemethod during the study period and for 6 months after the last dose of theinvestigational drug is administered (And male subjects do not donate sperm duringthis period, and female subjects do not donate eggs during this period; Femalesubjects must be non-pregnant and non-lactating female subjects, defined as women in astate of pregnancy from conception to termination of pregnancy, as determined bylaboratory human chorionic gonadotropin (hCG) test within 7 days before the start ofthe study;
  9. Voluntarily participate in this clinical trial, understand the study procedure andsign the informed consent before screening; Good compliance, willing to follow studyprocedures.

Exclusion

Exclusion Criteria:

  1. Patients with medical history or existing diseases of motor system, neuropsychiatricsystem, endocrine system, blood circulatory system, respiratory system, digestivesystem, urinary system, reproductive system, and other abnormalities, and thosedetermined by the investigator to be clinically significant ;
  2. A known or persistent mental disorder that may interfere with the participant'sparticipation in the study, as determined by the investigator;
  3. Known allergic history to food, environment, experimental drug ABSK-011 or otherdrugs;
  4. Participants who have participated in other clinical trials and used other clinicaltrial drugs or test devices within 3 months before or during the screening period, orplan to participate in other clinical trials during the study period, or participantswho do not participate in clinical trials themselves;\
  5. have previously participated in this study or any other study related to ABSK-011 as asubject and have taken ABSK-011;
  6. Patients who had used proton pump inhibitors (including omeprazole, Lansoprazole,Rabeprazole, pantoprazole, etc.) within 14 days before the first dose;
  7. Those who have used strong inhibitors or inducers of CYP3A4 (including grapefruitjuice, grapefruit hybrids, pomegranates, star fruits, grapefruits, Seville oranges andfruit juices or other processed products) within 14 days before the first dose, orhave used any prescription drugs, over-the-counter drugs, Chinese herbal medicines orhealth products;
  8. For those who have used CYP2C19 inhibitors or inducers (including fluoxetine,fluvoxamine, ticlopidine, rifamepine) within 14 days before the first dose, (Part Conly);
  9. There are factors that significantly affect drug absorption, distribution, metabolismand excretion, such as inability to take oral experimental drugs (dysphagia),significant nausea, vomiting and malabsorption, history of gastric or intestinalsurgery, or other surgical history that affects drug absorption, distribution,metabolism and excretion (except appendicitis surgery);
  10. Patients with needle fainting, blood fainting history, or inability to toleratevenipunction, or difficulty in blood collection;
  11. Blood donation or heavy blood loss (≥400ml) within 3 months before or during screening (except female menstrual period);
  12. Have special dietary requirements, can not comply with the unified diet (such as thestandard meal food intolerance, lactose intolerance, etc.) and the correspondingregulations, or have swallowing difficulties;
  13. Those who do not wish to comply with the dietary requirements/restrictions during thestudy period, which are: (i) only dietary supplements provided by the study centerduring hospitalization, (ii) avoiding CYP3A4 strong inhibitor or inducer during thestudy, and (iii) avoiding other CYP2C19 strong inhibitor or inducer during the study ( (iii) Only Part C);
  14. Those who consumed more than 14 units of alcohol per week in the 3 months prior toscreening (1 unit of alcohol is about 360mL beer or 45mL spirits with 40% alcohol or 150mL wine), or whose alcohol breath test results were > 0mg/100ml, or those whocannot abstain from alcohol during the study;
  15. Smokers who smoked more than 5 cigarettes per day (or a corresponding amount oftobacco or nicotine products) in the 3 months prior to screening; Or unable to stopusing any tobacco products during the trial;
  16. People who had excessive methylxanthine/caffeine consumption in the past 6 months (excess consumption was defined as consuming more than 6 units of caffeine per day,with 1 unit of caffeine equivalent to 177 ml of coffee, 355 ml of tea, 355 ml of cola,or 85 grams of chocolate), Or were unwilling to comply with themethylxanthine/caffeine use restrictions in 5.3.3 during the study period, or had aknown history of substance abuse or screened positive for substance abuse;
  17. Hepatitis B surface antigen, treponema pallidum antibody, antibody to humanimmunodeficiency virus, antibody to hepatitis C antibody were abnormal and wereclinically significant determined by the investigator;
  18. Patients with a history of bacterial, fungal, parasitic, viral (excludingnasopharyngitis) or mycobacterium infection within 45 days prior to the firstadministration, or imaging findings (chest radiograph) supporting related infections (as determined by the investigator);
  19. had been vaccinated within 2 months prior to the first dose, or intended to bevaccinated throughout the study period;
  20. Any other factors that the investigator considers inappropriate for participation inthis trial, which may affect the participant's adherence to the protocol, interferewith the interpretation of the study results, or expose the participant to risk. Orsubjects withdraw from the experiment for their own reasons.

Study Design

Total Participants: 73
Treatment Group(s): 2
Primary Treatment: Sequence A ABSK-011
Phase: 1
Study Start date:
February 23, 2024
Estimated Completion Date:
December 31, 2024

Study Description

This study consists of three separate parts: Part A, Part B and Part C. Part A is designed as a two-period, open-label, two-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new and old ABSK-011 capsules in a single oral dose.

Part B is designed as a three-period, open-label, three-sequence crossover study, the main objective of which is to evaluate the relative bioavailability and PK characteristics of new ABSK-011 formulation versus the old formulation at high and low doses for single oral administration.

Part C was designed as a four-period, open-label, fixed-sequence study, the main objective of which was to evaluate the effects of low-fat diet, high-fat diet and omeprazole magnesium enteric-coated tablets on PK of the new ABSK-011 formulation after a single oral administration.

Connect with a study center

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu 214062
    China

    Active - Recruiting

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