Antacid Interaction Study

Phase 1CompletedNCT01982201

Ardea Biosciences, Inc.24 enrolled

Overview

This study will assess the potential effects of calcium carbonate and aluminum/magnesium hydroxide-containing antacids on the pharmacokinetics (PK) and pharmacodynamics (PD) of lesinurad in healthy, adult male subjects.

In this study, lesinurad and antacid will be administered in the fed state, antacid doses will be attenuated to reflect the more commonly used doses, baseline PD assessments will be performed both in presence and absence of antacid treatment, and the sequence of treatments (lesinurad +/- antacid) will be randomized.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lesinurad 400 mgDRUG

Tums 500 mg and 750 mgDRUG

MINTOX 10 mLDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2. * 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 Screening or gave a plasma donation within 4 weeks prior to Screening. * Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Locations (1)

Unnamed facility

Kalamazoo, Michigan, United States

Outcomes

Primary Outcomes

PK profile of lesinurad from plasma and urine

Plasma in terms of maximum observed concentration (Cmax), time of occurrence of maximum observed concentration (Tmax), area under the concentration-time curve (AUC), apparent terminal half-life (t½), renal clearance (CLR), and adverse event (Ae).

Time frame: Day 2 and Day 7

PD profile of Lesinurad from serum and urine

Serum PD in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.

Time frame: Day 2 and Day 7

Secondary Outcomes

Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

Time frame: 5 weeks

Data from ClinicalTrials.gov

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