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Healthy SubjectsPhase 1NCT06322706

A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021

A Phase 1 study testing ABSK021 and Omeprazole in people with Healthy Subjects, run by Abbisko Therapeutics Co, Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
ABSK021 and Omeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
22 Mar 2024to 1 Nov 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Healthy subjects aged 18 to 45 years (inclusive) at Screening;
  • Weight ≥ 50.0 kg (male) or ≥ 45.0 kg (female), with a body mass index (BMI) between 19.0 and 28.0 (inclusive), BMI = weight (kg)/height (m)2;
  • 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;
  • 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 (see section 5.4 for details), and male subjects should not donate sperm during such period; female subjects should not donate ovum during such period and should not be pregnant or lactating. Pregnancy period is defined as the period from the date of conception until termination of pregnancy, and will be determined by laboratory test of human chorionic gonadotropin (hCG) within 7 days prior to initiation of the study;
  • 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.

Who cannot join

  • Past or current medical history of chronic or severe conditions in cardiovascular, respiratory, blood, liver, kidney, gastrointestinal, endocrine or nervous systems;
  • Known or persistent mental disorders that may preclude the subject from participation in the study, as determined by the investigator;
  • Past history of gastric or intestinal surgery, or other operations (except for appendectomy) affecting the drug absorption;
  • Dysphagia and inability to take the investigational product orally;
  • Intolerant to venipuncture, difficult to collect blood samples, and fear of needle sickness and blood;
  • Known allergy to two or more kinds of foods and drugs; or allergic to ABSK021 or its excipients (lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, gelatin), allergic to omeprazole; and prone to allergic reactions such as rash and urticaria;
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  • History of bacterial, fungal, parasitic, viral (excluding nasopharyngitis), mycobacterial infection, and COVID19 infection within 30 days prior to screening; or abnormal chest X-ray finding, assessed as clinically significant (by the investigator);
  • Symptoms of fatigue and pyrexia within 2 weeks prior to screening;
  • Abnormal laboratory tests: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) > 1 × ULN; Creatinine > 1 × ULN; Total Bilirubin (TBIL) > 1.5 × ULN; Creatine Kinase (CK) > 1.5 × ULN; amylase > 1 × ULN; Lactate Dehydrogenase (LDH) > 1.5 × ULN; Serum Potassium < Lower Limit of Normal (LLN); and hemoglobin < LLN;
  • Positive result for either of the following tests: serum Hepatitis B Surface Antigen (HBsAg), Hepatitis B e Antigen (HBeAg), Hepatitis B e Antibody (HBeAb), Hepatitis B Core Antibody (HBcAb), Hepatitis C Virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, and treponema pallidum antibody;
  • Pregnant or lactating women, or those with a positive pregnancy test;
  • Participated in any clinical studies of drugs as a study subject and received the study drug within 3 months prior to screening;
  • Previously participated in any other study related to ABSK021 and received ABSK021;
  • Used strong inhibitors or inducers of CYP3A4 (including grapefruit juice, grapefruit hybrids, punica granatum, carambola, citrus maxima, and Seville oranges [including its juices or other processed products]; see Appendix 12.2Contraindicated Medications and Products for Concomitant Use with ABSK021 or Omeprazole for the detailed list) within 14 days prior to screening and at Screening;
  • Used strong inhibitors or inducers of CYP2C19 (including Fluoxetine, Fluvoxamine, Ticlopidine, Rifampin, etc., see Appendix 12.2 Contraindicated Medications and Products for Concomitant Use with ABSK021 or Omeprazole for the detailed list) within 14 days prior to screening and at Screening;
  • Have special diet requirements and cannot accept to take a unified dietary; specific dietary requirements: (i) the subjects can only eat the food provided by the study site during hospitalization, (ii) the subjects should avoid using strong inhibitors or inducers of CYP3A4 during the study, and (iii) the subjects should avoid using other strong inhibitors or inducers of CYP2C19 during the study (see Appendix 12.2 Contraindicated Medications and Products for Concomitant Use with ABSK021 or Omeprazole for the detailed list);
  • Consumption of more than 14 units of alcohol per week (1 unit of alcohol = about 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to signing the informed consent form, or a positive result for alcohol breath test on the day pre-dose (breath alcohol content > 0.0 mg/100 mL), or unable to abstain from alcohol during the study;
  • Consumption of more than 5 cigarettes per day within 3 months prior to signing the informed consent form, or unable to abstain from tobacco products during the study;
  • Positive for nicotine test;
  • Previous chronic consumption of excessive amount of tea, coffee, or caffeinated beverages (excessive intake is defined as taking more than 6 units of caffeine per day, 1 unit of caffeine equivalent to 177 mL of coffee, 355 mL of tea, 355 mL of cola, or 85 g of chocolate) or unable to abstain from caffeinated beverages during the study;
  • Known history of drug abuse or positive for drug abuse screening test (morphine, methamphetamine, ketamine, methylene dioxyamphetamine, and tetrahydrocannabinol acid);
  • Used over the counter or prescription drugs, including herbal medicine, health products, vitamins, and dietary supplements, within 14 days prior to screening, or plan to use such drugs during the study;
  • Donated or lost > 400 mL of blood within 3 months prior to screening; received blood transfusions or used blood products within 2 months prior to screening;
  • Received vaccine (including COVID19 vaccine) within 2 months prior to screening, or plan to get vaccinated during the study;
  • Significant abnormalities in vital signs, including: ear temperature > 37.7 °C; pulse rate > 100 beats/min or < 50 beats/min; systolic blood pressure ≥ 140 mmHg or < 90 mmHg, diastolic blood pressure ≥ 90 mmHg or < 50 mmHg;
  • Heart rate-corrected QT interval prolongation, QTcF > 450 ms (> 470 ms for females) (Note: QTc interval corrected using the Fridericia formula), or family history of long QT syndrome, or other clinically significant ECG abnormalities at Screening;
  • Plan to donate sperm or ovum within 6 months after administration of the investigational product;
  • Subjects involving in the design or conduct of this study and their immediate family members (e.g., employees of Abbisko Therapeutics Co., Ltd., employees of the CRO, and employees of the study site);
  • Subjects who, in the opinion of the investigator, are not suitable for enrollment or may not be able to complete the study for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Wuxi People's Hospital

    Wuxi, JiangShu, 214023

Other trials in China

About this study

Official title: A Single-Center, Open-Label, Multi-Cycle Study to Evaluate the Pharmacokinetic Profile of Different Doses of ABSK021 Capsules and the Effect of a High-Fat Meal and Omeprazole Enteric-coated Tablets on the Pharmacokinetic Profile of ABSK021 Capsules in Healthy Subjects

Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects

Read the detailed description

Part A: in this part, 18 healthy subjects are planned to be enrolled and will be randomized to either Study Sequence A (Sequence A) or Study Sequence B (Sequence B) (with 9 subjects in each sequence) to receive single oral dose of ABSK021 separately for a total of 3 doses, separated by 10 days.

Part B: in this part, 18 healthy subjects are planned to be enrolled to receive single oral dose of ABSK021 in a fixed sequence separately for a total of 2 doses. Subjects will receive a single dose of 50 mg ABSK021 Capsules on the morning of Cycle 1 Day 1 (C1D1) under fasting conditions; and 40 mg Omeprazole once daily from Days 1 to 5 of Cycle 2 (C2D1 to C2D5); with the other single oral dose of 50 mg ABSK021 received 2 h after the dose of Omeprazole under fasting conditions on C2D5

Being tested
ABSK021, Omeprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABSK021Drug

    ABSK021 oral

  • OmeprazoleDrug

    Omeprazole oral

Study groups in NCT06322706
Study groupRoleWhat they receive
ABSK021ExperimentalNot described
Receives: Drug: ABSK021
ABSK021and OmeprazoleExperimentalNot described
Receives: Drug: ABSK021; Drug: Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

  2. tmax

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

  3. AUC0-∞

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

  4. AUClast

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

Secondary outcomes (8)

  1. AE

    The relationship of each adverse event to the investigational product will be assessed by CTCAE v5.0

    Measured: up to 3 months

  2. SAE

    The relationship of each serious adverse event to the investigational product will be assessed by CTCAE v5.0

    Measured: up to 3 months

  3. blood pressure

    blood pressure will be measured by sphygmomanometer

    Measured: up to 1 months

  4. respiratory rate

    respiratory rate will be measured by respiratory rate machine

    Measured: up to 1 months

  5. ECG QT Interval

    12-lead ECGs will be obtained during the study using an ECG machine

    Measured: predose up to 240 hours post-dose

  6. t1/2

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

  7. CL/F

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

  8. Vz/F

    PK samples were collected according to the protocol requirements

    Measured: predose up to 240 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start22 Mar 2024
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322706
Sponsor's protocol ID
ABSK021-105
Status last verified
Feb 2024
First submitted
29 Feb 2024
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABSK021 and Omeprazole in people with Healthy Subjects, run by Abbisko Therapeutics Co, 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 29 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: finished, as of the sponsor's last update on 18 Feb 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: predose up to 240 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06322706.

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 18 Feb 2025.

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