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

NCT04586803 | Unknown Phase 1

• 1 other identifier: SHR4640-Ⅰ-109
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Primary Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (3)

• Cmax

  Peak plasma concentration

  Day1 to Day25

• AUC0-t

  Area under the curve from the time of dosing. Dosing time to the last measurable (positive) concentration.

  Day1 to Day25

• AUC0-inf(if available)

  Area under the curve from time 0 to infinity

  Day1 to Day25

Secondary Outcomes (5)

• Tmax

  Day1 to Day25

• t1/2

  Day1 to Day25

• CL/F

  Day1 to Day25

• Vz/F

  Day1 to Day25

• PD

  Day1 to Day25

Study Arms (6)

A

EXPERIMENTAL

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.

Drug: SHR4640

B

EXPERIMENTAL

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.

Drug: SHR4640

C

EXPERIMENTAL

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.

Drug: SHR4640

D

EXPERIMENTAL

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.

Drug: SHR4640

E

EXPERIMENTAL

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.

Drug: SHR4640

F

EXPERIMENTAL

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.

Drug: SHR4640

Interventions

SHR4640 DRUG

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.

A; B; C; D; E; F

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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).

You may not qualify if:

• Subjects will not be allowed to enter this study if they meet any of the following criteria:
• \. General situation:
• Have a fertility plan within 3 months after screening to the last medication, or refuse to use medically approved contraceptive methods;
• Drug abusers or drug urine screening positive;
• Smokers (average daily smoking 5 or more) or urine Nicotin positive.
• 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);
• 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.
• The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
• \. Laboratory tests showed the following conditions:
• Those with sUA \> 420 µmol / L during the screening period, or those with a previous history of hyperuricemia and / or gout;
• Those with estimated glomerular filtration rate (eGFR) \< 90 during the screening period;
• Those with urolithiasis indicated or suspected by B ultrasound during the screening period;
• 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.
• \. There is any history of any of the following or concomitant diseases:
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Hyperuricemia

Interventions

ruzinurad

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zourong Ruan, PhD

  The Second Affiliated Hospital of Medical College of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Zhong, Master

CONTACT

13564101315; zhongsheng@hrglobe.cn

Yuxiong Gao, PhD

CONTACT

19821262236; gaoyuxiong@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2020
• First Posted: October 14, 2020
• Study Start: October 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share