NCT02336594

RDEA3170 Bioavailability Study

A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	RDEA3170 10 mg
DRUG	RDEA3170 2.5 mg

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2015-01-13
• Last updated: 2017-10-13
• Results posted: 2017-10-13

Locations

1 site across 1 country: United States