38 completed. 21 Phase 1, 9 Phase 2, 7 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 21 | Completed 21 |
| Phase 2 | 9 | Completed 9 |
| Phase 3 | 7 | Completed 7 |
| Phase 4 | 1 | Completed 1 |
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence. lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 32 | 2017-08-14 | 2018-11-07 |
| Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence lesinurad/allopurinol 200/300 FDC tablet, lesinurad 200 mg, allopurinol 300 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 28 | 2016-08-30 | 2017-06-16 |
| RDEA3170 PK/PD Study RDEA3170 4.5 mg, RDEA3170 6 mg, RDEA3170 12 mg - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 40 | 2015-11-01 | 2016-09-02 |
| Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability lesinurad/allopurinol 200/300 FDC tablets, lesinurad 200 mg, allopurinol 300 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 116 | 2015-10-01 | 2016-12-19 |
| Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects RDEA3170 2.5 mg, allopurinol 300 mg - Gout | Phase 2 | Completed | Ardea Biosciences, Inc. | 41 | 2015-07-28 | 2018-01-23 |
| RDEA3170 Tablet and Capsule Bioavailability Study RDEA3170,10 mg, RDEA3170, 2.5 mg, RDEA3170, 5 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 35 | 2015-05-01 | 2018-08-20 |
| DECT Study in Allopurinol-Treated Gout Patients DECT scan - Gout | Completed | Ardea Biosciences, Inc. | 223 | 2015-04-01 | 2017-01-25 | |
| IVIVR Assessing PK Parameters Used to Establish Bioequivalence Zyloprim® 300 mg, Allopurinol 300 mg; undergranulated, high hardness condition, Allopurinol 300 mg; alternative condition 2 - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 20 | 2015-04-01 | 2016-01-01 |
| A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients RDEA3170, Febuxostat, Benzbromarone - Gout and Asymptomatic Hyperuricemia | Phase 1 / Phase 2 | Completed | AstraZeneca | 110 | 2014-12-01 | 2015-06-12 |
| RDEA3170 Bioavailability Study RDEA3170 10 mg, RDEA3170 2.5 mg - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 15 | 2014-11-01 | 2017-10-13 |
| RDEA3170 and Allopurinol Combination Study in Gout Subjects RDEA3170 10 mg, allopurinol 300 mg - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 12 | 2014-11-01 | 2017-12-20 |
| RDEA3170 and Febuxostat Combination Study in Gout Subjects RDEA3170 15 mg, RDEA3170 10 mg, RDEA3170 2.5 - Gout | Phase 2 | Completed | Ardea Biosciences, Inc. | 64 | 2014-10-01 | 2017-07-27 |
| Mild, Moderate and Severe Renal Impairment Study RDEA3170 - Gout | Phase 1 | Completed | Ardea Biosciences, Inc. | 31 | 2014-08-01 | 2017-04-25 |
| Lesinurad Tablet Bioequivalence Lesinurad 400 mg (manufactured at Site 1), Lesinurad 400 mg (manufactured at Site 2) - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 54 | 2014-04-01 | 2014-09-22 |
| Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia RDEA3170, Allopurinol, Placebo - Gout and Hyperuricemia | Phase 2 | Completed | AstraZeneca | 204 | 2014-01-05 | 2019-09-24 |
| Bioavailability of Lesinurad and Intravenous [14C]Lesinurad Lesinurad 400 mg, [14C]lesinurad (100 μg per 10 mL) - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 10 | 2014-01-01 | 2014-05-20 |
| Lesinurad Tablet Relative Bioavailability Lesinurad 400 mg (Site 1), Lesinurad 400 mg (Site 2, Lot A), Lesinurad 400 mg (Site 2, Lot B) - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 36 | 2013-11-01 | 2014-09-22 |
| Antacid Interaction Study Lesinurad 400 mg, Tums 500 mg and 750 mg, MINTOX 10 mL - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 24 | 2013-11-01 | 2014-05-20 |
| Metformin and Furosemide Drug-Drug Interaction Study Lesinurad 400 mg, Metformin 850 mg, Furosemide 40 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 23 | 2013-10-01 | 2014-02-14 |
| RDEA3170 AME Study RDEA3170 10 mg - Healthy | Phase 1 | Completed | Ardea Biosciences, Inc. | 8 | 2013-08-01 | 2014-01-09 |
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Gout (22) · Hyperuricemia (3) · HIV Infections (1)
lesinurad (20) · verinurad (13) · Allopurinol (11) · Febuxostat (5) · Benzbromarone (1) · Calcium Carbonate (1) · Furosemide (1) · Indomethacin (1) · Metformin (1) · Naproxen (1) · Ranitidine (1) · aluminum hydroxide, magnesium hydroxide, simethicone drug combination (1)
United States (32) · Canada (10) · New Zealand (8) · Australia (7) · Germany (7) · Poland (6) · Belgium (5) · South Africa (5) · Switzerland (4) · Spain (3) · Ukraine (3) · United Kingdom (3) · Japan (2) · Brazil (1) · Bulgaria (1)
J. Hall, MD (6) · Chris Storgard, MD (5) · J. Hall (4) · Nihar Bhakta, MD (4) · N. Bhakta (3) · S Baumgartner, MD (2) · S Bradley, MD (2) · S. Baumgartner (2) · Vijay Hingorani, MD, PhD, MBA (2) · Chris Storgard (1) · J Hall, MD (1) · Jesse Hall, MD (1) · S. Bradley (1) · S. Bradley, MD (1) · Vijay Hingorani, MD, PhD (1)
PMID 35835008, PMID 32951150, PMID 20498326, PMID 26190562, PMID 26742777, PMID 27564409, PMID 27821644, PMID 28597604, PMID 29029210, PMID 29531784, PMID 29657831, PMID 29868853, PMID 29949102, PMID 30616614