A Randomized, Open-label, Single-dose, Two-period, Two-treatment Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of SY-5007 Tablets in Chinese Healthy Subjects

Shouyao Holdings (Beijing) Co. LTD1 site in 1 country28 target enrollmentApril 1, 2024

ConditionsHealth Subjects

InterventionsSY-5007

DrugsSY-5007

Overview

Phase: Phase 1
Intervention: SY-5007
Conditions: Health Subjects
Sponsor: Shouyao Holdings (Beijing) Co. LTD
Enrollment: 28
Locations: 1
Primary Endpoint: AUC0-∞ for SY-5007
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China.

Detailed Description

The study consists of two parts: a pilot study and a formal study. The pilot study involves four healthy subjects who will receive a single dose of SY-5007 80 mg after a meal (high-fat meal) for Period 1 and on an empty stomach for Period 2, with observation and PK blood sample collection. The formal study plans to enroll 24 healthy subjects, divided into Groups A and B, each with 12 subjects, receiving a dose of 160 mg. Group A will receive the drug on an empty stomach for Period 1, followed by administration after a meal (high-fat meal) for Period 2, while Group B will follow the reverse sequence. Both groups will adopt a two-period, two-treatment crossover design with a washout period of 7 days. If the pilot study results show a significant impact of food on the PK characteristics or safety of SY-5007, subsequent trial protocols may be adjusted.

Registry

clinicaltrials.gov

Start Date

April 1, 2024

End Date

May 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Shouyao Holdings (Beijing) Co. LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
•Fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate, and sign a written informed consent form (ICF), and be able to follow the protocol requirements to complete the study as healthy subjects.
•Aged ≥18 and ≤55 years old, regardless of gender (including boundary values, based on the time of signing the informed consent form).
•Male subjects with a body weight ≥50kg, female subjects with a body weight ≥45kg, and a body mass index (BMI = weight/height\^2, kg/m\^2) between 18 and 26 kg/m\^2 (including boundary values).
•Female subjects of childbearing potential and all male subjects agree to adopt effective contraception with their sexual partners during the study and for 3 months after the last dose, and have no plans to donate sperm/eggs during the trial and for 3 months after the end of the trial.

Exclusion Criteria

•Subjects will be ineligible for this study if they meet any of the following criteria:
•A clear history of severe allergies, non-allergic drug reactions, or multiple drug allergies, or known hypersensitivity reactions to the investigational drug (active pharmaceutical ingredient or excipients).
•Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, hepatitis C antibodies, or syphilis treponema antibodies at screening.
•Clinically significant abnormal vital signs, physical examination findings, laboratory test results, or electrocardiogram results at screening.
•Currently suffering from or known by the investigator to have chronic gastrointestinal, liver, or kidney diseases that may affect trial outcomes.
•Any symptoms or medical history of major diseases within the past two years, including but not limited to cardiovascular, hepatic, renal diseases, or other acute or chronic gastrointestinal diseases, respiratory diseases, musculoskeletal diseases, as well as diseases of the blood, endocrine, nervous, or psychiatric systems, or any other conditions or physiological states that may interfere with trial results.
•Any surgical conditions or conditions that may significantly affect drug absorption, distribution, metabolism, and excretion, or any surgical conditions or conditions that may pose harm to subjects participating in the trial, such as a history of gastrointestinal surgery (gastrectomy, gastrojejunal anastomosis, intestinal resection, etc.), urinary tract obstruction or difficulty in urination, history of digestive tract ulcers, gastrointestinal bleeding, etc. (Subjects who have undergone appendectomy or hernia repair surgery can be enrolled in the study).
•Known or suspected history of drug abuse within the past two years at screening, or drug abuse within the past three months at screening or baseline, or positive drug abuse screening during screening or baseline.
•Underwent major surgery within the past six months before the first dose or planning to undergo surgery during the trial.
•Smoked an average of more than 5 cigarettes per day within the past three months before the first dose or unwilling to stop using any tobacco products during the trial.