Overview

This trial is active, not recruiting.

Condition healthy
Treatments lesinurad/allopurinol 200/300 fdc tablet, lesinurad 200 mg, allopurinol 300 mg
Phase phase 1
Sponsor Ardea Biosciences, Inc.
Start date August 2016
End date October 2016
Trial size 28 participants
Trial identifier NCT02888054, RDEA594-503

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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)
lesinurad/allopurinol 200/300 fdc tablet
lesinurad 200 mg
allopurinol 300 mg
(Experimental)
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)
lesinurad/allopurinol 200/300 fdc tablet
lesinurad 200 mg
allopurinol 300 mg
(Experimental)
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)
lesinurad/allopurinol 200/300 fdc tablet
lesinurad 200 mg
allopurinol 300 mg
(Experimental)
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)
lesinurad/allopurinol 200/300 fdc tablet
lesinurad 200 mg
allopurinol 300 mg

Primary Outcomes

Measure
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
time frame: Days 1, 8, 15, and 22
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
time frame: Days 1, 8, 15, and 22
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
time frame: Days 1, 8, 15, and 22
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
time frame: Days 1, 8, 15, and 22
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
time frame: Days 1, 8, 15, 22

Secondary Outcomes

Measure
Incidence of Adverse Events in terms of changes in laboratory parameters
time frame: 8 weeks
Incidence of Adverse Events in terms of electrocardiogram parameters
time frame: 8 weeks
Incidence of Adverse Events in terms of vital signs
time frame: 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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-Gaultformula 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

Additional Information

Official title A Phase 1, Randomized, Open-Label, Replicate, Crossover Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects
Description The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ardea Biosciences, Inc..