Lesinurad Tablet Bioequivalence

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lesinurad 400 mg (manufactured at Site 1); Drug: Lesinurad 400 mg (manufactured at Site 2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02127775

RDEA594-132

Details and patient eligibility

About

This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Full description

This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
• Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion criteria

• Subject has any gastrointestinal disorder that affects motility and/or absorption.
• Subject has a history or suspicion of kidney stones.
• Subject has undergone major surgery within 3 months prior to Screening.
• Subject has donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
• Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Sequence B

Experimental group

Description:

Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)

Treatment:

Drug: Lesinurad 400 mg (manufactured at Site 1)

Drug: Lesinurad 400 mg (manufactured at Site 2)

Sequence A

Experimental group

Description:

Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)

Treatment:

Drug: Lesinurad 400 mg (manufactured at Site 1)

Drug: Lesinurad 400 mg (manufactured at Site 2)