ABSK091 Food Effect Study in Healthy Subjects

NCT05533788 | Completed Phase 1

• 1 other identifier: ABSK091-101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health, Subjective; Food-drug Interaction

Outcome Measures

Primary Outcomes (4)

• Cmax

  The PK parameters of Cmax

  9 days

• AUC(0-tlast)

  The PK parameters of AUC(0-tlast)

  9 days

• AUC(0-∞)

  The PK parameters of AUC(0-∞)

  9 days

• Tmax

  The PK parameters of Tmax

  9 days

Secondary Outcomes (1)

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

  9 days

Study Arms (2)

Fed states in healthy subjects

OTHER

Fed states in healthy subjects

Drug: ABSK091 tablet

Fasted states in healthy subjects

OTHER

Fasted states in healthy subjects

Drug: ABSK091 tablet

Interventions

ABSK091 tablet DRUG

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

Also known as: AZD4547 tablet

Fasted states in healthy subjects; Fed states in healthy subjects

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114202, Taiwan

Location

MeSH Terms

Interventions

AZD4547

Study Officials

• Yuan Lu, PhD

  Abbisko Therapeutics Co, Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: September 9, 2022
• Study Start: September 8, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

TW (1)