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Health, SubjectivePhase 1NCT05533788

ABSK091 Food Effect Study in Healthy Subjects

A Phase 1 study testing ABSK091 tablet in people with Health, Subjective and Food-drug Interaction, run by Abbisko Therapeutics Co, Ltd at 1 site in Taiwan.

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

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 a high-fat meal on the rate and extent of absorption and exposure. Read more about this study

Who is it for?
Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Health, Subjective, Food-drug Interaction
What is being tested?
ABSK091 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteTaiwan
Study dates
8 Sep 2020to 30 Apr 2021
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 20 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provision of signed and dated informed consent prior to any study specific procedures
  • aged 20 to 45 years, inclusive, at the time of screening
  • male subjects: agree to use an effective method of contraception and not donate sperm for the duration of the study and for 3 months following the last dose of ABSK091
  • female subjects: non-pregnant, non-lactating female subjects who if premenopausal are using adequate birth control, e.g., oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device/intrauterine system, tubal ligation, vasectomized sexual partner (with confirmed negative sperm counts) or true sexual abstinence. All females must have a negative serum pregnancy test within 7 days and a negative urine pregnancy test within 24 hours prior to dosing with ABSK091
  • have a body mass index (BMI) of 18.5 to 24.9 kg/m2, inclusive, and weigh at least 50 kg and no more than 90 kg, at screening
  • healthy subjects as determined by medical history and physical examination and have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • with suitable veins for cannulation or repeated vein puncture
  • are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Who cannot join

  • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
  • Have previously completed or withdrawn from this study or any other study investigating ABSK091, and have previously received the investigational product
  • Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data, 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 allergies to ABSK091, related compounds, or any components of the formulation, or history of significant atopy.
  • Have known or ongoing psychiatric disorders that would interfere with study participation as determined by the investigator.
Show all 27Show fewer
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of ABSK091 .
  • Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
  • Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
  • Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 ms (female >480 ms) or shortened QTcF <350 ms or family history of long QT syndrome.
  • Have an abnormal blood pressure as determined by the investigator.
  • Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV) .
  • Any of the following ophthalmological criteria.
  • Known or suspected history of drug abuse as judged by the Investigator.
  • 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 one month of screening or any blood. donation/blood loss >500 mL during the 3 months prior to screening
  • Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions as specified in Section 6.3.2 (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • are subjects who currently smoke more than 5 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by smoking restrictions as specified in Section 6.3.2
  • Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade or other products containing grapefruit or Seville oranges within 7 days before the first administration of the ABSK091
  • have a current or recent history (<30 days prior to screening and/or <45 days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
  • have had symptomatic herpes zoster within 3 months of screening
  • have received live vaccine(s) within 3 months of screening, or intend to during the study
  • are unwilling to comply with the dietary requirements/restrictions during the study.
  • have used or intend to use drugs or substances that are known to be strong or moderate inhibitors or inducers of CYP 3A4/5 and/or CYP2D6 within 30 days prior to the first dose and throughout the study.
  • Have a history of, in the opinion of the investigator, excessive methylxanthine use within the previous 6 months, or are unwilling to abide by restrictions as specified in Section 6.3.2. Excessive intake is defined as more than 6 units of caffeine per day; one caffeine unit is contained in the following items: 1 (177 mL) cup of coffee, 1 (355 mL) cup of tea, 2 (355 mL) cans of cola, or 3 oz (85 g) of chocolate
  • Involvement in the planning and/or conduct of the study (applies to Abbisko staff, CRO staff, and staff at the study site)
  • in the opinion of the investigator or sponsor, are unsuitable for inclusion in the study

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Tri-Service General Hospital

    Taipei, 114202

Other trials in Taiwan

About this study

Official title: A Randomized, Open-label, Two Sequence, Two-period Cross-over Study Evaluating the Relative Bioavailability of ABSK091 Single Dose Between Fed and Fasted States in Healthy Subjects

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 a high-fat meal on the rate and extent of absorption and exposure.

Study ABSK091-101 is a single-center, Phase 1, open-label, randomized, two-period, two-sequence, and crossover study in healthy subjects.

Being tested
ABSK091 tablet

What participants receive

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

  • ABSK091 tabletDrug

    Also called AZD4547 tablet

    ABSK091 tablet which is being developed for the treatment of patients with advanced solid tumors

Study groups in NCT05533788
Study groupRoleWhat they receive
Fed states in healthy subjectsOtherFed states in healthy subjects
Receives: Drug: ABSK091 tablet
Fasted states in healthy subjectsOtherFasted states in healthy subjects
Receives: Drug: ABSK091 tablet

What is being measured

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

  1. Cmax

    The PK parameters of Cmax

    Measured: 9 days

  2. AUC(0-tlast)

    The PK parameters of AUC(0-tlast)

    Measured: 9 days

  3. AUC(0-∞)

    The PK parameters of AUC(0-∞)

    Measured: 9 days

  4. Tmax

    The PK parameters of Tmax

    Measured: 9 days

Secondary outcomes (1)

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: 9 days

Timeline

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

  1. First posted9 Sep 2022
  2. Study start8 Sep 2020
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

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
Double blind
Who is masked
Participant, Investigator
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05533788
Sponsor's protocol ID
ABSK091-101
Status last verified
Sep 2022
First submitted
11 Oct 2021
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABSK091 tablet in people with Health, Subjective and Food-drug Interaction, run by Abbisko Therapeutics Co, Ltd at 1 site in Taiwan.

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 8 inclusion and 27 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 9 Sep 2022. 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 Taiwan. 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: 9 days). 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 NCT05533788.

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 9 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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