Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: lesinurad/allopurinol 200/200 FDC tablets; Drug: allopurinol 300 mg; Drug: lesinurad 200 mg; Drug: allopurinol 200 mg; Drug: lesinurad/allopurinol 200/300 FDC tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581553

RDEA594-501

Details and patient eligibility

About

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

Full description

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.

Enrollment: 116 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index ranging between 18 kg/m2 and 40 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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116 participants in 6 patient groups

Sequence AB

Experimental group

Description:

Day 1: lesinurad/allopurinol FDC tablets (Treatment A); Day 8: lesinurad + allopurinol (Treatment B)

Treatment:

Drug: lesinurad/allopurinol 200/300 FDC tablets

Drug: allopurinol 300 mg

Drug: lesinurad 200 mg

Sequence BA

Experimental group

Description:

Day 1: lesinurad + allopurinol (Treatment B); Day 8: lesinurad/allopurinol FDC tablets (Treatment A).

Treatment:

Drug: lesinurad/allopurinol 200/300 FDC tablets

Drug: allopurinol 300 mg

Drug: lesinurad 200 mg

Sequence CD

Experimental group

Description:

Day 1: lesinurad/allopurinol FDC tablets (Treatment C \[fasted\]); Day 8: lesinurad/allopurinol FDC tablets (Treatment D \[fed\]).

Treatment:

Drug: lesinurad/allopurinol 200/300 FDC tablets

Sequence DC

Experimental group

Description:

Day 1: lesinurad/allopurinol FDC tablets (Treatment D \[fed\]); Day 8: lesinurad/allopurinol FDC tablets (Treatment C \[fasted\]).

Treatment:

Drug: lesinurad/allopurinol 200/300 FDC tablets

Sequence EF

Experimental group

Description:

Day 1: lesinurad/allopurinol 200/200 FDC tablets (Treatment E); Day 8: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2)

Treatment:

Drug: allopurinol 200 mg

Drug: lesinurad/allopurinol 200/200 FDC tablets

Drug: lesinurad 200 mg

Sequence FE

Experimental group

Description:

Day 1: coadministered lesinurad 200 mg + allopurinol 200 mg (100 mg × 2) (Treatment F); Day 8: lesinurad/allopurinol 200/200 FDC tablets (Treatment E).

Treatment:

Drug: allopurinol 200 mg

Drug: lesinurad/allopurinol 200/200 FDC tablets

Drug: lesinurad 200 mg