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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Sperimentale: 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
Sperimentale: 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
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peak concentration (Cmax)
Lasso di tempo: 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-∞)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Yiqing Zhao, Bachelor, Affiliated Hospital of Jiangnan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

10 agosto 2026

Completamento dello studio (Stimato)

10 agosto 2026

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ABSK-011-104

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su ABSK-011 Capsules

3
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