Clinical trial NCT04620408: Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers
Official title: Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers (Single Center, Randomized, Open, Double Crossover)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-09
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of the study is to evaluate the effect of food on the pharmacokinetics of SHR4640 tablets in healthy volunteers. The secondary objective of the study is to observe the safety of SHR4640 tablets in healthy subjects.

Detailed description: Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily sign the informed consent form before the start of the activities related to this trial, and be able to understand the procedures and methods of this trial, and be willing to strictly abide by the clinical trial plan to complete this trial.
2. Aged between 18 and 45 years old (including both ends, whichever is the time of signing the informed consent form), male.
3. Body weight ≥ 50 kg, and body mass index (BMI): 19-26 kg/m2 (both ends included).

Exclusion Criteria:

1. Have a fertility plan within 3 months after screening to the last medication, or refuse to use medically approved contraceptive methods.
2. Drug abusers or drug urine screening positive.
3. Smokers (average daily smoking 5 or more).
4. Those who consumed more than 25 grams of alcohol per day during the first month were screened or were positive for alcohol breath test.
5. Anyone who had eaten grapefruit or fruit juice products within 2 days before administration, any food or drink containing caffeine (such as coffee, tea, chocolate, cola or other caffeinated carbonated drinks, etc.) and foods or drinks rich in purine food or alcohol.
6. The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
7. Those with sUA \> 420 µmol / L during the screening period, or those with a previous history of hyperuricemia and / or gout.
8. Those with estimated glomerular filtration rate (eGFR) \< 90 (mL/min/1.73 m²) during the screening period.
9. Those with urolithiasis indicated or suspected by B ultrasound during the screening period.
10. Those who were positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or syphilis antibody within one month or during the screening period.
11. Any clinical history of serious illness or disease or condition that the researchers believe may affect the results of the trial, including, but not limited to, a history of circulatory, endocrine, nervous, digestive, urinary or hematological, immune, mental and metabolic diseases.
12. People with allergies, including those who are explicitly allergic to research drugs or any ingredient in research drugs, are allergic to any food ingredient or have special requirements for diet, and are unable to follow a uniform diet.
13. Screening those who have undergone any operation within the first 3 months, or who have not recovered after the operation, or who may have a plan for operation or hospitalization during the trial.
14. Those who donated blood (or lost blood) within the first 3 months and donated blood (or lost blood) more than 400 mL, or received blood transfusion.
15. Screen people who have participated in clinical trials of any drug or medical device within the previous 3 months.
16. Take any prescription drug, over-the-counter medicine, Chinese herbal medicine or dietary supplement within 2 weeks before the screening period.

Primary outcomes:
measure: Cmax
timeFrame: Day1 to Day11
measure: AUC0-t
timeFrame: Day1 to Day11
measure: AUC0-inf
timeFrame: Day1 to Day11
Secondary outcomes:
measure: sUA
timeFrame: Day1 to Day11
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of the Chinese people's Liberation Army
name: Beibei Liang, PhD
role: PRINCIPAL_INVESTIGATOR
References: