Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.
The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | Day 1: lesinurad/allopurinol FDC tablets (Treatment A); Day 8: lesinurad + allopurinol (Treatment B) |
|
| Sequence BA | Experimental | Day 1: lesinurad + allopurinol (Treatment B); Day 8: lesinurad/allopurinol FDC tablets (Treatment A). |
|
| Sequence CD | Experimental | Day 1: lesinurad/allopurinol FDC tablets (Treatment C [fasted]); Day 8: lesinurad/allopurinol FDC tablets (Treatment D [fed]). |
|
| Sequence DC | Experimental | Day 1: lesinurad/allopurinol FDC tablets (Treatment D [fed]); Day 8: lesinurad/allopurinol FDC tablets (Treatment C [fasted]). |
|
| Sequence EF | Experimental | Day 1: lesinurad/allopurinol 200/200 FDC tablets (Treatment E); Day 8: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lesinurad/allopurinol 200/300 FDC tablets | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | Cmax is the maximum observed concentration of a drug after administration | Days 1 and Day 8 |
| PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | Tmax is the time of occurrence of cmax | Day 1 and Day 8 |
| PK endpoints in terms of area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint | Day 1 and Day 8 |
| PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | AUC 0-∞ is a meausre of total concentration from time zero to infinity | Day 1 and Day 8 |
| PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | t1/2 is a measure of apparent terminal half-life | Day 1 and Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events in terms of changes in laboratory parameters | 6 weeks | |
| Incidence of Adverse Events in terms of electrocardiogram parameters | 6 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| N. Bhakta | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2017 | |
| Reset | Jul 13, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2017 | Jul 13, 2018 |
| ID | Term |
|---|---|
| C000593471 | lesinurad |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sequence FE | Experimental | Day 1: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) (Treatment F); Day 8: lesinurad/allopurinol 200/200 FDC tablets (Treatment E). |
|
| lesinurad 200 mg |
| Drug |
|
| allopurinol 300 mg | Drug |
|
| lesinurad/allopurinol 200/200 FDC tablets | Drug |
|
| allopurinol 200 mg | Drug |
|
| Incidence of Adverse Events in terms of vital signs |
| 6 weeks |
| Incidence of Adverse Events in terms of physical examination findings | 6 weeks |