ABSK091 Food Effect Study in Healthy Subjects (NCT05533788) | Clinical Trial Compass
CompletedPhase 1
ABSK091 Food Effect Study in Healthy Subjects
Taiwan13 participantsStarted 2020-09-08
Plain-language 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.
Study ABSK091-101 is a single-center, Phase 1, open-label, randomized, two-period, two-sequence, and crossover study in healthy subjects.
Who can participate
Age range20 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕. 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.