RDEA3170 Bioavailability Study
| Status: | Completed |
|---|---|
| Conditions: | Gout |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/15/2017 |
| Start Date: | November 2014 |
| End Date: | March 2015 |
A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets
This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and
pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative
bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)
and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat
and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative
bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets)
and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat
and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.
Inclusion Criteria:
- Subject is able to understand the study procedures and the risks involved and is
willing to provide written informed consent before the first study-related activity
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2
- Subject has a Screening serum urate level ≤ 7 mg/dL
- 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 Day 1 or gave a plasma donation within 4 weeks prior to Day 1
- Subject has inadequate venous access or unsuitable veins for repeated venipuncture
- Subject has a Screening serum creatinine value above the upper limit of normal during
Screening or at Day -2 (Admission)
- Subject cannot swallow multiple tablets
- Subject is a heavy caffeine drinker
- Subject is unwilling to comply with the dietary restrictions of the study
- Subject is unable or unwilling to comply with the study requirements or has a
situation or condition that, in the opinion of the Investigator, may interfere with
participation in the study
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