Antacid Interaction Study
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/1/2014 |
| Start Date: | November 2013 |
| End Date: | April 2014 |
| Contact: | V. Clauson |
| Phone: | 858.652.6549 |
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
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.
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.
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.
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.
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