Status:
COMPLETED
A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Contract Research Organization: USA
PAREXEL Early Phase Clinical Unit Baltimore
Conditions:
Asymptomatic Hyperuricemia
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 (verinu...
Detailed Description
This is a randomized, placebo controlled, double-blind, 2-way crossover study to assess the effect of intensive UA lowering therapy with verinurad (RDEA3170), febuxostat, and dapagliflozin on urinary ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03316131
Start Date
October 25 2017
End Date
July 19 2018
Last Update
August 28 2019
Active Locations (2)
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1
Research Site
Glendale, California, United States, 91206
2
Research Site
Baltimore, Maryland, United States, 21225