At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
RDEA3170 10 mg +1 moredrug
Likely dose
RDEA3170 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets
In Brief
A Phase 1 clinical trial evaluating RDEA3170 10 mg and RDEA3170 2.5 mg for Gout. Completed, enrolled 15 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
Primary CompletionJan 2015
First PostedJan 2015
Study CompletionMar 2015
TodayJul 2026
First PostedJan 13, 2015
Enrollment StartNov 1, 2014
Primary CompletionJan 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.5 years ago
Interventions
RDEA3170 10 mgdrug
RDEA3170 2.5 mgdrug