Single Dose Study of SHR4640 in Healthy Subjects
- Registration Number
- NCT02815839
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Body weight≥50, BMI:19-24kg/m2;
- Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female;
- Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
Exclusion Criteria
- History of hyperuricemia or gout.
- Pregnancy or breastfeeding;
- History or suspicion of kidney stones;
- serum creatinine>1.5mg/dl for male, >1.2mg/dl for female;
- alanine aminotransferase and/or aspartate aminotransferase>2 upper limit of normal, or total bilirubin>2.5 upper limit of normal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3 Placebo 7.5-mg SHR4640 or placebo Cohort 1 Placebo 2.5-mg SHR4640 or placebo Cohort 4 SHR4640 10-mg SHR4640 or placebo Cohort 5 SHR4640 20-mg SHR4640 or placebo Cohort 2 Placebo 5-mg SHR4640 or placebo Cohort 4 Placebo 10-mg SHR4640 or placebo Cohort 5 Placebo 20-mg SHR4640 or placebo Cohort 1 SHR4640 2.5-mg SHR4640 or placebo Cohort 2 SHR4640 5-mg SHR4640 or placebo Cohort 3 SHR4640 7.5-mg SHR4640 or placebo
- Primary Outcome Measures
Name Time Method Adverse events Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) up to day 4; up to day 11 for 7.5mg dose group Half-time (T1/2) up to day 4; up to day 11 for 7.5mg dose group AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group up to day 11 Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group up to day 11 Changes in serum uric acid concentration from baseline up to day 4; up to day 11 for 7.5mg dose group absolute and percent changes in serum acid concentration
Changes in urinary uric acid excretion from baseline up to day 4; up to day 11 for 7.5mg dose group percent changes in urinary uric acid excretion from baseline
Peak Plasma Concentration (Cmax) up to day 4; up to day 11 for 7.5mg dose group Time to the peak plasma concentration (Tmax) up to day 4; up to day 11 for 7.5mg dose group Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group up to day 11 T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group up to day 11
Trial Locations
- Locations (1)
Southwest Hospital
🇨🇳Chongqing, Sichuan, China
Southwest Hospital🇨🇳Chongqing, Sichuan, China