A Randomized, Open, Single-dose, Two-cycle, Two-sequence, Cross-over Design Phase I Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profile of a Single Oral DA-302168S Tablet in Healthy Subjects

Chendu DIAO Pharmaceutical Group CO., LTD.1 site in 1 country16 target enrollmentJuly 18, 2024

ConditionsOverweight and Obesity

Interventions15 mg DA-302168S tablet

Drugs15 mg DA-302168S tablet

Overview

Phase: Phase 1
Intervention: 15 mg DA-302168S tablet
Conditions: Overweight and Obesity
Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD.
Enrollment: 16
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will be conducted to determine the effect of food on the pharmacokinetics characteristic of DA-302168S following administration of a DA-302168S tablet with and without a high-fat meal.

Detailed Description

This study plans to enroll 16 participants. Qualified subjects will be randomly assigned to one of two dosing sequences (The first group will receive DA-302168S tablets on an fasting condition, followed by administration after high-fat meals. The second group adopts the opposite administration methods) in a 1:1 ratio. Each administration sequence consists of two cycles, with one administration per cycle and a 5-day washout period between each administration.

Registry

clinicaltrials.gov

Start Date

July 18, 2024

End Date

August 3, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Chendu DIAO Pharmaceutical Group CO., LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 55 years old (including 18 and 55 years old), male or female.
•Weight: male ≥50kg, female ≥45kg, body mass index (BMI) in the range of 19.0 \~ 28.0kg/m2 (including the end value).
•Subjects and their spouses or partners did not plan to become pregnant or plan to donate sperm or ovum during the study period until 3 months after the last dose, and agreed to use at least one acceptable and effective contraceptive method
•Subjects and their spouses or partners did not plan to become pregnant or plan to donate sperm or eggs during the study period until 3 months after the last dose, and agreed to use at least one acceptable and effective contraceptive method.
•No clinically significant abnormalities identified in the judgement of investigator at screening.
•Written informed consent prior to any study specific procedures.

Exclusion Criteria

•subjects with a history of abnormal clinical presentation, diseases to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, endocrine system, renal, hepatic, gastrointestinal, respiratory, metabolic, and skeletal systems, and a history of malignant tumors, which are judged to be clinically significant by the Investigator.
•Use of any medication (including prescription, over-the-counter, herbal, etc.) or nutraceutical within 14 days prior to the first dose.
•May have any contraindications, allergies or hypersensitivity to DA-302168S Tablets (both test drug and placebo) or its excipients, GLP-1RA, DPP-4 analogues.
•Previous family history of medullary thyroid carcinoma or type 2 multiple endocrine adenoma syndrome.
•History or evidence of any of the following conditions:
•decompensated heart failure (New York Heart Association (NYHA) Cardiac Classification III and IV \[Appendix 5: NYHA Heart Failure Classification\]), cardiac arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second or third degree atrioventricular block, QTcF intervals \> 450 milliseconds for men or \> 470 milliseconds for women \[Appendix 8: Fridericia Method Corrected QT Interval Formula\], PR intervals \> 220 milliseconds, etc.) prior to the first administration of the study drug. (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, grade II or III AV block, QTcF interval \>450 ms in males or \>470 ms in females \[Appendix 8: Formula for Correcting QT Intervals by the Fridericia Method\], PR interval \>220 ms, etc.) and who, in the opinion of the investigator, are unsuitable for participation in this study;
•Serious trauma or acute infection that may affect glycemic control within 4 weeks prior to screening;
•Positive results for any of the Hepatitis B Surface Antigen, Hepatitis C Antibody, Syphilis Spirochete Antibody, or Human Immunodeficiency Virus (HIV) Antibody;
•Mental or neurological illness prior to screening, unwillingness to communicate, or a language barrier that prevents full understanding and cooperation;
•Other medical or psychiatric conditions that may increase the risk of participation in the study or that, in the judgment of the Investigator, may make the subject unsuitable for participation in the study, including a recent history (within the past two years) of major depression or other serious mental disorder, or any history of attempted suicide.