Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence
Study Details
Study Description
Brief Summary
This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence ABBA Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) |
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
|
| Experimental: Sequence BABA Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) |
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
|
| Experimental: Sequence ABAB Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) |
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
|
| Experimental: Sequence BAAB Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) |
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets [Days 1, 8, 15, and 22]
Cmax is the maximum observed concentration of a drug after administration
- PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets [Days 1, 8, 15, and 22]
Tmax is the time of occurrence of cmax
- PK endpoints in terms of area under plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets [Days 1, 8, 15, and 22]
AUC last is a measure of total plasma concentration from time zero to the last measurable concentration
- 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 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets [Days 1, 8, 15, and 22]
AUC 0-∞ is a measure of total concentration from time zero to infinity
- PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets [Days 1, 8, 15, 22]
t1/2 is a measure of apparent terminal half-life
Secondary Outcome Measures
- Incidence of Adverse Events in terms of changes in laboratory parameters [8 weeks]
- Incidence of Adverse Events in terms of electrocardiogram parameters [8 weeks]
- Incidence of Adverse Events in terms of vital signs [8 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject has a body mass index ranging between 18 kg/m2 and 30 kg/m2.
-
Screening serum urate level is ≤ 7.0 mg/dL.
Exclusion Criteria:
-
Asian subject who has a positive test for the HLA-B*5801 allele.
-
History or suspicion of kidney stones.
-
Estimated creatinine clearance, as determined at Screening, of < 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
-
Undergone major surgery within 3 months prior to Screening.
-
Donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1.
-
Inadequate venous access or unsuitable veins for repeated venipuncture.
-
Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Ardea Biosciences, Inc.
Investigators
- Study Director: N. Bhakta, Ardea Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RDEA594-503