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A Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole Enteric-Coated Tablets on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants

8. juli 2026 opdateret af: Abbisko Therapeutics Co, Ltd

A Single-Center, Open-Label, Multiple-Period Study to Evaluate the Effects of Low-Fat Meal, High-Fat Meal and Omeprazole on the Pharmacokinetics of ABSK-011 Capsules in Healthy Participants

This study consists of two parts: Part A and Part B. Part A is a single-center, randomized, open-label, three-period study intended to evaluate the effects of low-fat and high-fat meals on the pharmacokinetic profiles of ABSK-011 Capsules. A total of 15 healthy participants are planned to be enrolled. Participants will be randomized to Sequence A, Sequence B or Sequence C at a 1:1:1 ratio and receive a single oral dose of ABSK-011 (50 mg × 4) on three separate occasions with a 4-day washout interval between administrations. 39 PK blood sampling time points will be collected in Part A.

Part B is a single-center, open-label, fixed-sequence study designed to assess the impact of multiple oral doses of omeprazole enteric-coated tablets on the pharmacokinetic profiles of ABSK-011 Capsules. 15 healthy participants are planned for enrollment. On Day 1 of Cycle 1 (C1D1), participants will receive 200 mg ABSK-011 Capsules in the morning after a low-fat meal. From Day 1 to Day 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. 26 PK blood sampling time points will be collected in Part B.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Healthy subjects aged 18 to 45 years (inclusive) at screening;
  2. Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female);
  3. Normal or abnormal but not clinically significant results in medical history, physical examination, clinical laboratory tests and other relevant examinations as assessed by the investigator at Screening;
  4. Male or female subjects of childbearing potential must agree to use effective methods of contraception during the study and within 6 months after the last dose of investigational product;
  5. Willing to participate in this study, understand the study procedures and sign the informed consent form prior to screening; willing to comply with the study procedures.

Exclusion Criteria:

  1. Patients with medical history or existing diseases of motor system, neuropsychiatric system, endocrine system, blood circulatory system, respiratory system, digestive system, urinary system, reproductive system, and other abnormalities, and those determined by the investigator to be clinically significant ;
  2. Known allergic history to food, environment, experimental drug ABSK-011 or other drugs;
  3. Participants who have participated in other clinical trials and used other clinical trial drugs or test devices within 3 months before or during the screening period, or plan to participate in other clinical trials during the study period, or participants who do not participate in clinical trials themselves;
  4. have previously participated in this study or any other study related to ABSK-011 as a subject and have taken ABSK-011;
  5. Patients who had used proton pump inhibitors (including omeprazole, Lansoprazole, Rabeprazole, pantoprazole, etc.) within 14 days before the first dose;
  6. Those who have used strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, pomegranates, star fruits, grapefruits, Seville oranges and fruit juices or other processed products) within 14 days before the first dose, or have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products;
  7. For those who have used CYP2C19 inhibitors or inducers (including fluoxetine, fluvoxamine, ticlopidine, rifamepine) within 14 days before the first dose, (Part B only);
  8. There are factors that significantly affect drug absorption, distribution, metabolism and excretion, such as inability to take oral experimental drugs (dysphagia), significant nausea, vomiting and malabsorption, history of gastric or intestinal surgery, or other surgical history that affects drug absorption, distribution, metabolism and excretion (except appendicitis surgery);
  9. Patients with needle fainting, blood fainting history, or inability to tolerate venipunction, or difficulty in blood collection;
  10. Blood donation or heavy blood loss (≥400ml) within 3 months before or during screening (except female menstrual period);
  11. Have special dietary requirements, can not comply with the unified diet (such as the standard meal food intolerance, lactose intolerance, etc.) and the corresponding regulations, or have swallowing difficulties;
  12. Those who do not wish to comply with the dietary requirements/restrictions during the study period, which are: (i) Only consume meals provided by the study center during hospitalization; (ii) Avoid P-gp inhibitors throughout the study period;(iii) Avoid moderate and strong CYP3A4 inhibitors or inducers throughout the study period;(iv) Avoid other strong CYP2C19 inhibitors or inducers throughout the study period.
  13. Those who consumed more than 14 units of alcohol per week in the 3 months prior to screening (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 who cannot abstain from alcohol during the study;
  14. Smokers who smoked more than 5 cigarettes per day (or a corresponding amount of tobacco or nicotine products) in the 3 months prior to screening; Or unable to stop using any tobacco products during the trial;
  15. 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 the methylxanthine/caffeine use restrictions in 5.3.3 during the study period, or had a known history of substance abuse or screened positive for substance abuse;
  16. Hepatitis B surface antigen, treponema pallidum antibody, antibody to human immunodeficiency virus, antibody to hepatitis C antibody were abnormal and were clinically significant determined by the investigator;
  17. Participants with a history of bacterial, fungal, parasitic, viral (excluding nasopharyngitis) or mycobacterium infection within 45 days prior to the first administration, or imaging findings (chest radiograph) supporting related infections (as determined by the investigator);
  18. had been vaccinated within 2 months prior to the first dose, or intended to be vaccinated throughout the study period;
  19. Any other factors that the investigator considers inappropriate for participation in this trial, which may affect the participant's adherence to the protocol, interfere with the interpretation of the study results, or expose the participant to risk. Or subjects withdraw from the experiment for their own reasons.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence A
Participants in Sequence A will receive 200 mg ABSK-011 Capsules orally under fasted conditions on the morning of Day 1 of Cycle 1 (C1D1), followed by 200 mg ABSK-011 Capsules after a low-fat meal on the morning of Day 1 of Cycle 2 (C2D1), and 200 mg ABSK-011 Capsules after a high-fat meal on the morning of Day 1 of Cycle 3 (C3D1).
ABSK-011 Capsules
Eksperimentel: Sequence B
Participants in Sequence B will receive 200 mg ABSK-011 Capsules after a low-fat meal on the morning of C1D1, 200 mg ABSK-011 Capsules after a high-fat meal on the morning of C2D1, and 200 mg ABSK-011 Capsules under fasted conditions on the morning of C3D1.
ABSK-011 Capsules
Eksperimentel: Sequence C
Participants in Sequence C will receive 200 mg ABSK-011 Capsules after a high-fat meal on the morning of C1D1, 200 mg ABSK-011 Capsules under fasted conditions on the morning of C2D1, and 200 mg ABSK-011 Capsules after a low-fat meal on the morning of C3D1.
ABSK-011 Capsules
Eksperimentel: Omeprazole + Low-Fat Meal + ABSK-011
Participants will receive 200 mg ABSK-011 Capsules following a low-fat meal on the morning of Day 1 of Cycle 1 (C1D1). During Days 1 to 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. On C2D5, a low-fat meal will be provided 1.5 hours (±1 minute) after omeprazole administration, and a single oral dose of 200 mg ABSK-011 Capsules will be administered 2 hours (±1 minute) after omeprazole intake.
ABSK-011 Capsules
ABSK-011 Capsules、omeprazole enteric-coated tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak concentration (Cmax)
Tidsramme: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Peak concentration, the maximum observed plasma concentration of ABSK-011
pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Tidsramme: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Area under the plasma concentration-time curve from time 0 to infinity of ABSK-011
pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUClast)
Tidsramme: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Area under the plasma concentration-time curve from time 0 to the last measurable concentration of ABSK-011
pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Time to maximum plasma concentration (tmax)
Tidsramme: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours
Time to maximum plasma concentration of ABSK-011
pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours,5 hours, 6 hours, 10 hours, 24 hours, 48 hours,72 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Yiqing Zhao, Bachelor, Affiliated Hospital of Jiangnan University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

10. august 2026

Studieafslutning (Anslået)

10. august 2026

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ABSK-011-104

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ABSK-011 Capsules

3
Abonner