Antacid Interaction Study

A Phase 1, Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interaction Between Lesinurad and Calcium Carbonate and Aluminum/Magnesium Hydroxide-Containing Antacids in Healthy Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982201

Enrollment

Registered

2013-11-13

Start date

2013-11-30

Completion date

2014-03-31

Last updated

2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Detailed description

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.

Interventions

DRUGLesinurad 400 mg

DRUGTums 500 mg and 750 mg

DRUGMINTOX 10 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
PK profile of lesinurad from plasma and urine	Day 2 and Day 7	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).
PD profile of Lesinurad from serum and urine	Day 2 and Day 7	Serum PD in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.

Secondary

Measure	Time frame
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters	5 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026