ABSK021 Food Effect Study in Healthy Subjects

NCT05280483 | Completed Phase 1 FDA Drug

• 1 other identifier: ABSK021-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (4)

• Cmax

  Pharmacokinetics parameters in fasting state and fed state

  4 weeks

• AUC0-∞

  Pharmacokinetics parameters in fasting state and fed state

  4 weeks

• AUC0-t

  Pharmacokinetics parameters in fasting state and fed state

  4 weeks

• Tmax

  Pharmacokinetics parameters in fasting state and fed state

  4 weeks

Secondary Outcomes (1)

• Adverse Events

  Through study completion, an average of 4 weeks

Study Arms (2)

Fed states in healthy subjects

EXPERIMENTAL

A single 25mg dose of ABSK021 administered in a fed state.

Drug: ABSK021 with fed state

Fasted states in healthy subjects

EXPERIMENTAL

A single 25mg dose of ABSK021 administered in a fasted state.

Drug: ABSK021 with fasted state

Interventions

ABSK021 with fed state DRUG

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

Fed states in healthy subjects

ABSK021 with fasted state DRUG

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

Fasted states in healthy subjects

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jing Zhang

  Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• 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: March 7, 2022
• First Posted: March 15, 2022
• Study Start: July 23, 2022
• Primary Completion: August 31, 2022
• Study Completion: May 26, 2023
• Last Updated: August 12, 2024

Record last verified: 2022-02

Locations

CN (1)