NCT01883167

RDEA3170 and Febuxostat Drug Interaction Study

A Phase 1 Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Febuxostat in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RDEA3170 10 mg	RDEA3170 10 mg once daily (qd)
DRUG	Febuxostat 40 mg	Febuxostat 40 mg qd
DRUG	placebo	placebo qd

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2013-06-21
• Last updated: 2014-01-09

Locations

1 site across 1 country: United States