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

• Status: Completed
• Trial end date: 2018-07-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborators: Analytical Laboratory (Pharmacokinetic Sample Analysis): USA; Clinical Laboratory: USA; Contract Research Organization: USA; Covance Bioanalytical Services, LLC; GenX Laboratories Inc.; Harbor Hospital Laboratory; PAREXEL Early Phase Clinical Unit Baltimore; PAREXEL Early Phase Clinical Unit-Los Angeles
• Treatments: Dapagliflozin; Febuxostat; Uric Acid; Verinurad

Criteria

Inclusion Criteria:

1. 18 to 65 years old

2. Asymptomatic hyperuricemia (sUA > 6.0 mg/dL)

3. Body mass index between 18 and 35 kg/m2 inclusive and weight at least 50 kg and no more than 150 kg

4. Females must be non-pregnant, as well as post-menopausal or willing to use an acceptable method of contraception during the study.

Exclusion Criteria:

1. 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

2. eGFR* < 45 mL/minute/1.73 m2 at Screening.

3. Type 2 diabetes mellitus with HbA1c >8%.

4. History of diabetic ketoacidosis, hyperosmolar non-ketotic coma, gout, or alcohol or drug abuse.

5. Ongoing treatment with an SGLT2-inhibitor, a URAT1-inhibitor, and/or a xanthine oxidase inhibitor.

6. Positive test for hepatitis B, hepatitis C or HIV.

7. Use of any medications in the 2 weeks preceding first administration of study drug.