Antacid Interaction Study
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.
Drug: Lesinurad 400 mg
Drug: Tums 500 mg and 750 mg
Drug: MINTOX 10 mL
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||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|
- PK profile of lesinurad from plasma and urine [ Time Frame: Day 2 and Day 7 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 2 and Day 7 ] [ Designated as safety issue: No ]Serum PD in terms of serum urate concentration, urine uric acid excretion amount, renal clearance of uric acid, and fractional excretion of uric acid.
- Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Lesinurad and Tums
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
|Drug: Lesinurad 400 mg Drug: Tums 500 mg and 750 mg|
Experimental: Lesinurad and MINTOX
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
|Drug: Lesinurad 400 mg Drug: MINTOX 10 mL|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01982201
|United States, Michigan|
|Kalamazoo, Michigan, United States, 49007|
|Study Director:||J. Hall||Ardea Biosciences, Inc.|