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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hyperuricemia; Primary Gout
• Intervention / Treatment: Drug: SHR4640

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Zhong, Master; Phone Number: +86 13564101315; Email: zhongsheng@hrglobe.cn
• Study Contact Backup: Name: Yuxiong Gao, PhD; Phone Number: +86 19821262236; Email: gaoyuxiong@hrglobe.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• 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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; 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; 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.
Experimental: B; 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; 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.
Experimental: C; 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; 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.
Experimental: D; 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; 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.
Experimental: E; 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; 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.
Experimental: F; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time of maximum observed concentration	Day1 to Day25
t1/2	Half time	Day1 to Day25
CL/F	apparent clearance	Day1 to Day25
Vz/F	apparent volume of distribution	Day1 to Day25
PD	concentration of serum urine acid	Day1 to Day25

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Zourong Ruan, PhD, The Second Affiliated Hospital of Medical College of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: SHR4640-Ⅰ-109

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