Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia

Hyperuricemia Clinical Trial

Official title:

Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia (Asymptomatic and Gout)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185793
• Other study ID #: SHR4640-201
• Status: Completed
• Phase: Phase 2
• Start date: July 20, 2017
• Est. completion date: July 20, 2018

Study information

• Verified date: August 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18-70 years, male or female;

2. Subject meets one of the following conditions:

1) Subject with a history of gout has a serum uric acid =480µmol/l at screening; 2) Subject with a history of hyperuricemia has a serum uric acid =540µmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) Subject with a history of hyperuricemia has a serum uric acid=480µmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2= BMI =32kg/m2.

Exclusion Criteria:

1. Subject who is pregnant or breastfeeding;

2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin>1.5 upper normal limit;

3. Estimated glomerular filtration rate (MDRD formula) ?60ml/min;

4. HbA1c?8%;

5. Subject with known hypersensitivity or allergy to SHR4640 or any component of SHR4640;

6. Subject with a history of malignancy;

7. Subject with a history of urolithiasis, or positive findings on ultrasound examination at screen

8. Subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack;

9. Subject has acute gout flares within 2 weeks before randomization;

10. Subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study;

11. Subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study;

12. Subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

Drug:
• Placebo
Placebo once daily for 5 weeks
• SHR4640
1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
• benzbromarone
25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks

Locations

Country	Name	City	State
China	Jiangsu Hengrui Medicine Co., Ltd.	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with a serum uric level=360µmol/l.		Week 5
Secondary	Actual change from baseline in serum uric level.		Week 5
Secondary	Percentage change from baseline in serum uric level .		Week 5
Secondary	Rate of gout flares requiring treatment.		Up to week 5
Secondary	Incidence of gout flares requiring treatment.		Up to week 5
Secondary	Proportion of subjects with a serum uric level=360µmol/l		At week1, 2, 3 and 4
Secondary	Proportion of subjects with a serum uric level consistent =360µmol/l		At week 3, 4 and 5
Secondary	Actual change from baseline in serum uric level		At week 1, 2, 3 and 4
Secondary	Percentage change from baseline in serum uric level		At week 1, 2, 3 and 4