A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA

Completed · Phase 2 · Has a placebo group

Conditions studied: Asymptomatic Hyperuricemia

In brief

This is a randomized, placebo controlled, double-blind, 2-way crossover study conducted on asymptomatic hyperuricemic patients. The core study consists of screening period, 2 treatment periods (verinurad + febuxostat + dapagliflozin/placebo) and follow-up visit

Key facts

Study ID

NCT03316131

Run by

AstraZeneca

People needed

36

Starts

2017-10-25

Expected to finish

2018-07-19

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 65 years old
• Asymptomatic hyperuricemia (sUA > 6.0 mg/dL)
• Body mass index between 18 and 35 kg/m2 inclusive and weight at least 50 kg and no more than 150 kg
• Females must be non-pregnant, as well as post-menopausal or willing to use an acceptable method of contraception during the study.

You may not qualify if…

• History of any clinically significant disease or disorder putting the patient at risk during the study, or influencing study results or ability to participate in the study
• eGFR* < 45 mL/minute/1.73 m2 at Screening.
• Type 2 diabetes mellitus with HbA1c >8%.
• History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, gout, or alcohol or drug abuse.
• Ongoing treatment with an SGLT2-inhibitor, a URAT1-inhibitor, and/or a xanthine oxidase inhibitor.
• Positive test for hepatitis B, hepatitis C or HIV.
• Use of any medications in the 2 weeks preceding first administration of study drug.

Where it is running

• Research Site — Glendale, California, United States
• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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