RDEA3170 Bioavailability Study

Ardea Biosciences, Inc.15 enrolled

Overview

This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gout

Interventions

RDEA3170 10 mgDRUG

RDEA3170 2.5 mgDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity * 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 a history or suspicion of kidney stones * Subject has undergone major surgery within 3 months prior to Screening * Subject 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 Day 1 * Subject has inadequate venous access or unsuitable veins for repeated venipuncture * Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission) * Subject cannot swallow multiple tablets * Subject is a heavy caffeine drinker * Subject is unwilling to comply with the dietary restrictions of the study * Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study

Locations (1)

Unnamed facility

Austin, Texas, United States