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NeoplasmsPhase 1NCT05280483

ABSK021 Food Effect Study in Healthy Subjects

A Phase 1 study testing ABSK021 with fed state and ABSK021 with fasted state in people with Neoplasms, 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

This is a randomized, open-label, two-sequence, two-cycle, cross-over study to evaluate the relative bioavailability of ABSK021 after single-dose fasting and high-fat postprandial administration in healthy subjects Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Neoplasms
What is being tested?
ABSK021 with fed state and ABSK021 with fasted state
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
23 Jul 2022to 26 May 2023
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 (male or female), age greater than or equal to 18 years and less than or equal to 45 years, single-sex subjects should no less than 4;
  • Weight ≥50 kg (≥45 kg for female), and have a body mass index (BMI) between 19 and 28 (including 19 and 28) at screening, BMI = weight (kg) / height (m) 2;
  • Physical examination, clinical laboratory examination and other related examinations are normal or acceptable deviations that are judged to be not clinically significant by the investigator;
  • Male or female subjects with child-bearing potential must agree to use effective contraception during the study and within 6 months after the administration of the last dose (see 5.4 for details), and sperm donation is not allowed for male subjects during the study; female subjects must be non-pregnant and non-lactating；pregnancy is defined as post-conception until termination of pregnancy in female， which determined by laboratory human chorionic gonadotropin (hCG) testing within 7 days prior to the first dose of this study;
  • Volunteer to participate in this study, understand the study procedures and sign the informed consent prior to any study specific procedures, good compliance and willing to follow study procedures.

Who cannot join

  • Have a history of or current cardiovascular, respiratory, hematological, hepatic, renal, gastrointestinal, endocrine, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study;
  • Have known or ongoing psychiatric disorders that would interfere with study participation as determined by the investigator;
  • Have known allergy to any drug or food;
  • Have participated in a clinical trial involving an investigational product within the last 3 months;
  • Have previously completed or withdrawn from this study or any other study investigating ABSK021, and have previously received the investigational product;
  • Have used drugs or substances that are known to be strong inhibitors or inducers of CYP3A4 within 14 days prior to the first dose (include grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, Seville oranges or juice or products);
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  • Have known factors that significantly affect drug absorption, distribution, metabolism, excretion, such as inability to take oral medication or significant nausea and vomiting, and malabsorption;
  • Unwilling to comply with the dietary requirements/restrictions during the study, the dietary requirements: (i) consume only the meals provided by the research center during inpatient visits, (ii) refrain from consuming strong inhibitors or inducers of CYP3A4 during the study.
  • Have an average weekly alcohol intake that exceeds 14 units within 3 months prior to screening (1 unit of alcohol is approximately 360mL of beer or 45mL of spirits with 40% alcohol content or 150mL of wine), positive for alcohol screening, or unwilling to abide by alcohol restrictions as specified in Section 5.3.3;
  • Smoking more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) within 3 months prior to screening, or unwilling to abide by smoking restrictions as specified in Section 5.3.3;
  • Have a history of, in the opinion of the investigator, excessive methylxanthine/caffeine use within the previous 6 months, or unwilling to abide by restrictions as specified in Section 5.3.3. Excessive intake is defined as more than 6 units of caffeine per day; one caffeine unit is contained in 177 mL of coffee, 355 mL of tea, 355 mL of cola, or 85g of chocolate；
  • Any positive result on screening for 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 and human immunodeficiency virus (HIV) antibody;
  • have a recent history (<45 days prior to the first dose) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection, or significantly abnormal CT examination results of chest as determined by the investigator;
  • Known history of drug abuse or have the positive results of drug abuse screening;
  • Have used or intend to use over-the-counter or prescription medication , including herbal medications, within 14 days prior to dosing and during the study;
  • Plasma donation within 30 days prior to screening or any blood donation/blood loss >500 mL during the 3 months prior to screening;
  • Have received live vaccine(s) within 2 months prior to screening, or intend to during the study;
  • The personnel involved in the planning and/or conduct of the study and their immediate family members (applies to Abbisko staff, CRO staff, and staff at the study site);
  • Abnormal vital signs, including:
  • Ear temperature >37.5℃;
  • Pulse>100 beats/min, or <50 beats/min;
  • Systolic blood pressure ≥140 mmHg or <90 mmHg, diastolic blood pressure ≥90 mmHg or <50 mmHg;
  • History of gastric and intestinal surgery, or other surgical history that affects drug absorption (except appendicitis surgery);
  • Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms (female >480 ms), or family history of long QT syndrome, or have an abnormal ECG with clinical symptoms as determined by the investigator；
  • Any other clinically significant comorbidities, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 201203

Other trials in China

About this study

Official title: A Randomized, Open-label, Two-sequence, Two-cycle, Cross-over Study to Evaluate the Relative Bioavailability of ABSK021 After Single-dose Fasting and High-fat Postprandial Administration in Healthy Subjects

This is a randomized, open-label, two-sequence, two-cycle, cross-over study to evaluate the relative bioavailability of ABSK021 after single-dose fasting and high-fat postprandial administration in healthy subjects

Read the detailed description

This is a single-center, arandomized, open label, two-sequence, two-cycle, cross-over study. Up to 16 healthy subjects will be enrolled in this study. Subjects will be randomized into sequence A or sequence B (8 subjects in each study sequence), and receive single oral doses of ABSK021 on 2 occasions separated by a washout period of at least 14 days (7 half-life of ABSK021 in human). Screening will occur up to 28 days prior to the first dose. And the end of treatment visit will occur 14 days after the last dose of ABSK021.

Conditions
Neoplasms
Being tested
ABSK021 with fed state, ABSK021 with fasted state
Medical subject headings
Neoplasms

What participants receive

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

  • ABSK021 with fed stateDrug

    25 mg ABSK021 (1x25 mg ABSK021 capsule) with food

  • ABSK021 with fasted stateDrug

    25 mg ABSK021 (1x25 mg ABSK021 capsule) without food

Study groups in NCT05280483
Study groupRoleWhat they receive
Fed states in healthy subjectsExperimentalA single 25mg dose of ABSK021 administered in a fed state.
Receives: Drug: ABSK021 with fed state
Fasted states in healthy subjectsExperimentalA single 25mg dose of ABSK021 administered in a fasted state.
Receives: Drug: ABSK021 with fasted state

What is being measured

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

  1. Cmax

    Pharmacokinetics parameters in fasting state and fed state

    Measured: 4 weeks

  2. AUC0-∞

    Pharmacokinetics parameters in fasting state and fed state

    Measured: 4 weeks

  3. AUC0-t

    Pharmacokinetics parameters in fasting state and fed state

    Measured: 4 weeks

  4. Tmax

    Pharmacokinetics parameters in fasting state and fed state

    Measured: 4 weeks

Secondary outcomes (1)

  1. Adverse Events

    Safety and tolerability measure by number of subjects who experience adverse events

    Measured: Through study completion, an average of 4 weeks

Timeline

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

  1. First posted15 Mar 2022
  2. Study start23 Jul 2022
  3. Primary completion31 Aug 2022
  4. Study completion26 May 2023

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
In this study, a single oral dose of the tablet formulation administered under fed conditions will be compared to administration under fasted conditions to assess the effects of high-fat meal on the rate and extent of absorption and exposure.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280483
Sponsor's protocol ID
ABSK021-102
Status last verified
Feb 2022
First submitted
7 Mar 2022
Last updated
12 Aug 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABSK021 with fed state and ABSK021 with fasted state in people with Neoplasms, 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 25 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 12 Aug 2024. 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: 4 weeks). 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 NCT05280483.

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 12 Aug 2024.

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