NCT02498652

Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	RDEA3170 2.5 mg	Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets). Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).
DRUG	allopurinol 300 mg	allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)

Timeline

• Start date: 2015-07-28
• Primary completion: 2015-11-19
• Completion: 2016-06-02
• First posted: 2015-07-15
• Last updated: 2018-01-23
• Results posted: 2018-01-23

Locations

4 sites across 1 country: United States