A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects

NCT06325761 | Not Yet Recruiting Phase 1

• 1 other identifier: SY-5007-I-02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Subjects

Keywords

SY-5007 tablets; Food effect; Two-period crossover

Outcome Measures

Primary Outcomes (7)

• Cmax for SY-5007

  Defined as maximum observed plasma concentration

  Day 1-Day 15

• Tmax for SY-5007

  Defined as time to maximum plasma concentration

  Day 1-Day 15

• AUC0-t for SY-5007

  Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration

  Day 1-Day 15

• AUC0-∞ for SY-5007

  Defined as area under the single-dose plasma concentration-time curve from Hour 0 to infinity

  Day 1-Day 15

• t½ for SY-5007

  Defined as apparent plasma terminal phase disposition half-life

  Day 1-Day 15

• CL/F for SY-5007

  Defined as apparent total body clearance

  Day 1-Day 15

• Vz/F for SY-5007

  Defined as apparent oral Volume of distribution

  Day 1-Day 15

Secondary Outcomes (1)

• Safety of SY-5007

  Day 1-Day 22

Study Arms (2)

Fasted dosing followed by fed dosing

EXPERIMENTAL

A single oral dose in the fasted state at Period 1 followed by fed dosing at Period 2

Drug: SY-5007

Fed dosing followed by fasted dosing

EXPERIMENTAL

A single oral dose in the fed state at Period 1 followed by fasted dosing at Period 2

Drug: SY-5007

Interventions

SY-5007 DRUG

SY-5007 160 mg, Tablets, 2 discrete single doses separated by 7-days

Fasted dosing followed by fed dosing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Regularly consumed alcohol within the past three months before the first dose (defined as consuming more than 14 units of alcohol per week, with 1 unit equal to 360 mL of beer with an alcohol content of 5%, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine with an alcohol content of 12%), or unable to stop drinking during the trial, or positive alcohol breath test at screening.
• History of blood donation or significant blood loss (≥300 mL) within the past two years before the first dose, or use of blood products or receiving blood transfusions within the past month before the first dose.
• Participated in other drug or medical device clinical trials within the past three months before the first dose (excluding those screened but ultimately not enrolled), or used the study drug before.
• Received vaccination or inactivated vaccines within the past month before the first dose.
• Used any prescription drugs, non-prescription drugs, health products, or herbal medicines within the past two weeks before the first dose (if the half-life (t1/2) of the drug used can be confirmed, the washout period should be ≥5 t1/2, with the longer one taken).

Sponsors & Collaborators

• Shouyao Holdings (Beijing) Co. LTD: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Yinghui Sun, Dr

  Shouyao Holdings (Beijing) Co. LTD

  STUDY DIRECTOR

Central Study Contacts

Yinghui Sun, Dr

CONTACT

86-10-88858616; yhsun@centaurusbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CN (1)