Antacid Interaction Study

NCT01982201 — Phase 1, Completed, 24 participants, Ardea Biosciences, Inc.

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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

Registry	NCT01982201
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	24 (Actual)
Sponsor	Ardea Biosciences, Inc. (Industry)
Conditions	Healthy
Interventions	Lesinurad 400 mg, Tums 500 mg and 750 mg, MINTOX 10 mL (Drug)
Dates	start 2013-11-01, primary completion 2013-12-01, completion 2014-03-01, first posted 2013-11-13, last updated 2014-05-20
Locations	1 site in United States

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Lesinurad and Tums	Experimental	Drug: Lesinurad 400 mg; Drug: Tums 500 mg and 750 mg	Day 1: 240 mL water or 240 mL water and Tums Day 2: Lesinurad 400 mg or Lesinurad 400 mg and Tums; Day 6: 240 mL water and Tums or 240 mL water; Day 7: Lesinurad 400 mg and Tums or Lesinurad 400 mg
Lesinurad and MINTOX	Experimental	Drug: Lesinurad 400 mg; Drug: MINTOX 10 mL	Day 1: 240 mL water or 240 mL water and MINTOX ; Day 2: Lesinurad 400 mg or Lesinurad 400 mg and MINTOX; Day 6: 240 mL water and MINTOX or 240 mL water; Day 7: Lesinurad 400 mg and MINTOX or Lesinurad 400 mg

Lesinurad 400 mg (Drug)
Tums 500 mg and 750 mg (Drug)
MINTOX 10 mL (Drug)

+Outcome measures

Primary outcomes

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 outcomes

Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [5 weeks]

+Eligibility

Sex: Male, ages: 18 Years to 55 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
	Kalamazoo, Michigan	United States

+Investigators

J. Hall, Study director, Ardea Biosciences, Inc.