NCT02815839
Completed
Phase 1
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Gout; Hyperuricemia
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Cohort 5
20-mg SHR4640 or placebo
Intervention: Placebo
Cohort 3
7.5-mg SHR4640 or placebo
Intervention: SHR4640
Cohort 3
7.5-mg SHR4640 or placebo
Intervention: Placebo
Cohort 4
10-mg SHR4640 or placebo
Intervention: SHR4640
Cohort 4
10-mg SHR4640 or placebo
Intervention: Placebo
Cohort 5
20-mg SHR4640 or placebo
Intervention: SHR4640
Cohort 2
5-mg SHR4640 or placebo
Intervention: Placebo
Cohort 1
2.5-mg SHR4640 or placebo
Intervention: SHR4640
Cohort 1
2.5-mg SHR4640 or placebo
Intervention: Placebo
Cohort 2
5-mg SHR4640 or placebo
Intervention: SHR4640
Outcomes
Primary Outcomes
Adverse events
Time Frame: Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
Secondary Outcomes
- 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)
- Changes in urinary uric acid excretion from baseline(up to day 4; up to day 11 for 7.5mg dose group)
- 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)
Study Sites (1)
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