Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers

Hyperuricemia Clinical Trial

Official title:

Study on the Bioavailability of Three Different Prescription Processes of SHR4640 Tablets in Healthy Volunteers (Single Center, Randomized, Open, 3 Cycles, 6 Sequences)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04586803
• Other study ID #: SHR4640-?-109
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 2020
• Est. completion date: December 2020

Study information

• Verified date: October 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Sheng Zhong, Master
• Phone: 13564101315
• Email: zhongsheng[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the relative bioavailability of three different prescription processes of SHR4640 tablets in healthy volunteers. The secondary objective of the study is to observe the safety of SHR4640 tablets in healthy subjects.

Description:

Study Type: Interventional Enrollment: Number of Subjects: 24 Type: Anticipated

Allocation : Yes Intervention Model : Single center, randomized, open Intervention Model Description: 3 cycles, 6 sequences Masking: No Masking

Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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:

• Subjects will not be allowed to enter this study if they meet any of the following criteria:

1. General situation:

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) or urine Nicotin positive.

4. The average daily alcohol intake during the first month was more than 25 g (for example, 750 mL beer, 250 mL wine or 50 mL low spirits);

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.

2. Laboratory tests showed the following conditions:

1. Those with sUA > 420 µmol / L during the screening period, or those with a previous history of hyperuricemia and / or gout;

2. Those with estimated glomerular filtration rate (eGFR) < 90 during the screening period;

3. Those with urolithiasis indicated or suspected by B ultrasound during the screening period;

4. 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.

3. There is any history of any of the following or concomitant diseases:

1. 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.

2. 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;

3. 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;

4. 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.

4. Use any of the following drugs or participate in clinical trials:

1. Screen people who have participated in clinical trials of any drug or medical device within the previous 3 months;

2. Take any prescription drug, over-the-counter medicine, Chinese herbal medicine or dietary supplement within 2 weeks before the screening period.

Related Conditions & MeSH terms

• Hyperuricemia
• Primary Gout

Intervention

Drug:
• SHR4640
Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Peak plasma concentration	Day1 to Day25
Primary	AUC0-t	Area under the curve from the time of dosing. Dosing time to the last measurable (positive) concentration.	Day1 to Day25
Primary	AUC0-inf(if available)	Area under the curve from time 0 to infinity	Day1 to Day25
Secondary	Tmax	Time of maximum observed concentration	Day1 to Day25
Secondary	t1/2	Half time	Day1 to Day25
Secondary	CL/F	apparent clearance	Day1 to Day25
Secondary	Vz/F	apparent volume of distribution	Day1 to Day25
Secondary	PD	concentration of serum urine acid	Day1 to Day25