Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Gout

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03272425

RDEA594-504

Details and patient eligibility

About

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index ranging between 18.5 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 current diagnosis of kidney stones.
• Estimated creatinine clearance, as determined at Screening, of ≤ 80 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
• Undergone major surgery within 3 months prior to Screening.
• Donated blood within 4 weeks prior to Day 1 or experienced an event (other than blood donation) of significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or 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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32 participants in 4 patient groups

Sequence ABBA

Experimental group

Description:

Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

Treatment:

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablets

Drug: allopurinol 300 mg

Sequence BABA

Experimental group

Description:

Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

Treatment:

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablets

Drug: allopurinol 300 mg

Sequence ABAB

Experimental group

Description:

Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

Treatment:

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablets

Drug: allopurinol 300 mg

Sequence BAAB

Experimental group

Description:

Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

Treatment:

Drug: lesinurad 200 mg

Drug: lesinurad/allopurinol 200/300 FDC tablets

Drug: allopurinol 300 mg