Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers

Study on the Food Effects of Oral SHR4640 Tablets in Healthy Volunteers (Single Center, Randomized, Open, Double Crossover)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: SHR4640

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; The subjects in group A did not have breakfast at D1, then were given an SHR4640 tablet. The subjects in group A had a high-fat breakfast on D8. After eating 30min, the subjects in group A were given SHR4640 tablet.	Drug: SHR4640; Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.
Experimental: Group B; Group B had high-fat breakfast on D1, no breakfast on D8, and the rest was the same as group A.	Drug: SHR4640; Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed concentration,	Day1 to Day11
AUC0-t	Area under the curve from the time of dosing Dosing time to the last measurable (positive) concentration.	Day1 to Day11
AUC0-inf	Area under the curve from time 0 to infinity	Day1 to Day11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sUA	concentration of serum urine acid	Day1 to Day11

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Beibei Liang, PhD, General Hospital of the Chinese People's Liberation Army

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SHR4640-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No