RDEA3170 Bioavailability Study
Completed · Phase 1
Conditions studied: Gout
In brief
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.
Key facts
- Study ID
- NCT02336594
- Run by
- Ardea Biosciences, Inc.
- People needed
- 15
- Starts
- 2014-11-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2017-10-13
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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