Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02888054

RDEA594-503

Details and patient eligibility

About

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

Full description

The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Sequence ABBA

Experimental group

Description:

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)

Treatment:

Drug: allopurinol 300 mg

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablet

Sequence BABA

Experimental group

Description:

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)

Treatment:

Drug: allopurinol 300 mg

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablet

Sequence ABAB

Experimental group

Description:

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)

Treatment:

Drug: allopurinol 300 mg

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablet

Sequence BAAB

Experimental group

Description:

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)

Treatment:

Drug: allopurinol 300 mg

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablet