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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 2.5-mg SHR4640 or placebo |
|
| Cohort 2 | Experimental | 5-mg SHR4640 or placebo |
|
| Cohort 3 | Experimental | 7.5-mg SHR4640 or placebo |
|
| Cohort 4 | Experimental | 10-mg SHR4640 or placebo |
|
| Cohort 5 | Experimental | 20-mg SHR4640 or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR4640 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | up to day 4; up to day 11 for 7.5mg dose group | |
| Area under the plasma concentration versus time curve (AUC) | up to day 4; up to day 11 for 7.5mg dose group | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Chongqing | Sichuan | 400038 | China |
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| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000720748 | ruzinurad |
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| Drug |
|
| Half-time (T1/2) |
| 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 |
| AUC 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 |
| 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 | absolute and percent changes in serum acid concentration | up to day 4; up to day 11 for 7.5mg dose group |
| Changes in urinary uric acid excretion from baseline | percent changes in urinary uric acid excretion from baseline | up to day 4; up to day 11 for 7.5mg dose group |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |