A Food-drug Interaction Study of SY-004 in Healthy Subjects

Type 2 Diabetes Clinical Trial

Official title:

A Randomized, Open-label, Two-period, Double Crossover, Single Center Study to Evaluate the Effect of High-fat Diet on the Pharmacokinetics of SY-004 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04907006
• Other study ID #: SY004004
• Status: Completed
• Phase: Phase 1
• Start date: August 31, 2021
• Est. completion date: October 11, 2021

Study information

• Verified date: May 2021
• Source: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, open, two cycle, double crossover, single center study was conducted to evaluate the effect of high-fat diet on the pharmacokinetics of SY-004 in healthy subjects

Description:

This study will evaluate the effect of high-fat diet on the pharmacokinetics of SY-004.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 11, 2021
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and sign the informed consent voluntarily.

• Age on the day of signing the informed consent: healthy subjects aged 18 or above, both male and female.

• At the time of screening, male weight = 50.0 kg, female weight = 45.0 kg, 19.0 kg / m2 = BMI = 26.0 kg / m2.

• Fasting blood glucose = 3.9 mmol / L and < 6.1 mmol / L.

• From one month before the informed consent to three months after the last medication, the subjects and their partners had no plans to have a child, take effective contraceptive measures voluntarily, and donate sperm or eggs.

Exclusion Criteria:

• Within 3 months before screening, a clinical trial was completed or withdrawn, or a clinical trial was currently in progress, or other medical trials were conducted. The researchers judged that it was not suitable for the trial.

• In the past, there were serious systematic diseases or family history (including cardiovascular system, digestive system, urinary system, etc.), the researchers judged that the disease status could significantly change the absorption, distribution, metabolism and excretion of the drug used in the trial, or the risk of the subjects would be increased by taking the trial drug.

• Allergic constitution, or food allergy history, or known to be allergic to study drug / similar drug.

• Previous history of hypoglycemia.

• Previous patients with postural hypotension.

• The past five years have been positive for drug abuse, drug use history or urine drug screening results.

• Those who donate blood or lose more than 400ml of blood within 4 weeks before screening, or who have received blood or blood component infusion within 4 weeks before screening, or who plan to donate blood components within 3 months after the end of the study.

• Those who have history of syncope or blood sickness, who cannot tolerate venous puncture or have difficulty in blood collection.

• Severe infection, trauma or surgical operation within 4 weeks prior to screening, or those who are scheduled to perform surgery during the study (including, but not limited to, dental operations).

• Use any prescription, over-the-counter, herbal or health care product within 2 weeks prior to screening.

• Any drugs that inhibit or induce the metabolism of liver drugs were used within 30 days before screening.

• The average alcohol intake in the first three months of screening was more than 14 units per week (1 unit = 360ml beer, 45ml of alcohol content of 40% spirits or wine 150ml), or those who could not give up drinking alcohol during the test, or those who were positive for alcohol exhalation.

• Smoking was = 5 cigarettes per day within 3 months before screening, or unwilling / unable to give up smoking during the trial.

• Special requirements for diet, and those who cannot comply with the unified diet arrangement.

• No guarantee of chocolate, any caffeine or food or drink (such as Firedragon fruit, grapefruit, grapefruit, orange juice, mango, etc.) 48 hours before and during the test.

• Pregnant or lactating women, or pregnant women with positive results.

• The results of screening were positive for HBsAg, HCV, TP and HIV.

• ALT > 1.5 times of normal value was found in screening( × ULN), or glutamic transaminase (AST) >1.5 × ULN, or serum total bilirubin (TBIL) > 1.5 × ULN?

• The results of 12 lead ECG were: QT interval (qtcb) >450ms (male) or >470ms (female).

• The results of physical examination, vital signs, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), chest CT, ECG, laboratory examination items and related auxiliary examination results were judged by the researchers to be unsuitable for the participants.

• The researchers judged that the subjects with other factors were not suitable for participating in the test.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• SY-004 capsule
After fasting for 10 hours, subjects in group 1 took one SY-004 (80mg) orally on an empty stomach on the day of administration with 240ml warm water; Subjects in group 2 began to eat high-fat breakfast 30 minutes before administration , and took one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups were fasted within 4 hours after taking the medicine, and drinking water was forbidden within 1 hour before and after taking SY-004.

Locations

Country	Name	City	State
China	XIE Haitang	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t	Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC) 0-t of SY-004 in human plasma.	8 days
Primary	AUC0-8	Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC)0 - 8 of SY-004 in human plasma.	8 days
Primary	Cmax	Under fasting and high-fat diet, Peak Plasma Concentration (Cmax) of SY-004 in human plasma.	8 days
Secondary	Tmax?t1/2z?CLz/F	Under fasting and high-fat diet, Peak time(Tmax) of SY-004 in human plasma.	8 days
Secondary	t1/2z	Under fasting and high-fat diet, Half life (T1/2z) of SY-004 in human plasma.	8 days
Secondary	CLz/F	Under fasting and high-fat diet, clearance (Cl) of SY-004 in human plasma.	8 days