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| ID | Type | Description | Link |
|---|---|---|---|
| RDEA3170-205 | Other Identifier | Ardea Biosciences, Inc. |
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| Name | Class |
|---|---|
| Ardea Biosciences, Inc. | INDUSTRY |
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The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 10mg, RDEA3170 2.5 mg + Febuxostat 10mg, RDEA3170 2.5 mg + Febuxostat 20mg, and Febuxostat 20mg. The other half will be dosed in the reverse order. |
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| Cohort 2 | Experimental | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 10mg, RDEA3170 5 mg + Febuxostat 10mg, RDEA3170 5 mg + Febuxostat 20mg, and Febuxostat 20mg. The other half will be dosed in the reverse order. |
|
| Cohort 3 | Experimental | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 20mg, RDEA3170 5 mg + Febuxostat 20mg, RDEA3170 5 mg + Febuxostat 40mg, and Febuxostat 40mg. The other half will be dosed in the reverse order. |
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| Cohort 4 | Experimental | The half of patients randomized to this cohort will be dosed in the order of Febuxostat 20mg, RDEA3170 10 mg + Febuxostat 20mg, RDEA3170 10 mg + Febuxostat 40mg, and Febuxostat 40mg. The other half will be dosed in the reverse order. |
|
| Cohort 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA3170 | Drug | Oral Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum uric acid level | % change per treatment will be compared. | baseline and day 7 on each treatment |
| Change in Urinary excretion of uric acid | Timed urinary uric acid excretion per treatment will be compared | baseline and day 7 on each treatment |
| Renal clearance of uric acid | Renal clearance of uric acid will be calculated. | baseline and day 7 on each treatment |
| Fractional excretion of uric acid | Fractional excretion and renal clearance of uric acid will be calculated. | baseline and day 7 on each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment |
| Time to reach maximum concentration (tmax) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary pH | To evaluate the relationship between the doses of uralyt and urinary pH under the administration of RDEA3170. | baseline and day 7 on each treatment |
| Deoxyribonucleic acid polymorphism |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32951150 | Derived | Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19. | |
| 29868853 | Derived | Shiramoto M, Liu S, Shen Z, Yan X, Yamamoto A, Gillen M, Ito Y, Hall J. Verinurad combined with febuxostat in Japanese adults with gout or asymptomatic hyperuricaemia: a phase 2a, open-label study. Rheumatology (Oxford). 2018 Sep 1;57(9):1602-1610. doi: 10.1093/rheumatology/key100. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2017 | |
| Reset | Jan 24, 2018 | |
| Release | Jul 12, 2018 | |
| Reset | Jan 11, 2019 | |
| Release | Feb 20, 2019 | |
| Reset | May 31, 2019 | |
| Release | Jul 29, 2019 | |
| Reset | Sep 6, 2019 | |
| Release | Jan 3, 2020 | |
| Reset | Jan 15, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2017 | Jan 24, 2018 | |||
| Jul 12, 2018 |
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000628929 | verinurad |
| D000069465 | Febuxostat |
| D001553 | Benzbromarone |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Experimental |
RDEA3170 2.5mg, RDEA3170 5mg, RDEA3170 10mg, RDEA3170 15mg |
|
| Cohort 6 | Experimental | The half of patients randomized to this cohort will be dosed in the order of Benzbromarone 50 mg, Febuxostat 10mg+RDEA3170 2.5 mg, then Febuxostat 20mg+RDEA3170 5 mg. The other half will be dosed in the order of Febuxostat 10mg+RDEA3170 2.5 mg, Febuxostat 20mg+RDEA3170 5 mg, then Benzbromarone 50mg. |
|
| Febuxostat | Drug | Oral Treatment |
|
| Benzbromarone | Drug | Oral Treatment |
|
To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.
| 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment |
| Area under the concentration-time curve (AUC) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment |
| Half life (t1/2) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment |
| Incidence of adverse events | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 1 and Day 7 on each treatment |
| Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 1 and Day 8 on each treatment |
| Changes in vital signs and physical examination findings | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 1 and Day 8 on each treatment |
| Incidence of adverse events | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 42 of the study as follow up |
| Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 42 of the study as follow up |
| Changes in vital signs and physical examination findings | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 42 of the study as follow up |
To collect and store deoxyribonucleic acid (DNA) for future exploratory research.
| Day 1 of the study as randomization |
| Change in Serum uric acid level | % change per treatment will be compared. | Baseline and day 7 on each treatment for cohort 6 |
| Change in Urinary excretion of uric acid | Timed urinary uric acid excretion per treatment will be compared. | Baseline and day 7 on each treatment for cohort 6 |
| Renal clearance of uric acid | Renal clearance of uric acid will be calculated. | Baseline and day 7 on each treatment for cohort 6 |
| Fractional excretion of uric acid | Fractional excretion and renal clearance of uric acid will be calculated. | Baseline and day 7 on each treatment for cohort 6 |
| Jan 11, 2019 |
| Feb 20, 2019 | May 31, 2019 |
| Jul 29, 2019 | Sep 6, 2019 |
| Jan 3, 2020 | Jan 15, 2020 |
| 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |