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Antacid Interaction Study

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ClinicalTrials.gov Identifier: NCT01982201
Recruitment Status : Completed
First Posted : November 13, 2013
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lesinurad 400 mg Drug: Tums 500 mg and 750 mg Drug: MINTOX 10 mL Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2013
Primary Completion Date : December 2013
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. PK profile of lesinurad from plasma and urine [ Time Frame: 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).

  2. PD profile of Lesinurad from serum and urine [ Time Frame: 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 Outcome Measures :
  1. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982201


Locations
United States, Michigan
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: J. Hall Ardea Biosciences, Inc.
More Information

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01982201     History of Changes
Other Study ID Numbers: RDEA594-130
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Lesinurad
Antacids
Aluminum hydroxide, magnesium hydroxide, drug combination
Uricosuric Agents
Gout Suppressants
Antirheumatic Agents
Renal Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents