Phase 2
N=36
A Study to Assess the Effect of Intensive Uric Acid (UA) Lowering Therapy With RDEA3170, Febuxostat, Dapagliflozin on Urinary Excretion of UA
Asymptomatic Hyperuricemia
Bottom Line
View on ClinicalTrials.gov: NCT03316131 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 — -12.87; -13.15 milligrams (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Verinurad (Drug); Febuxostat (Drug); Dapagliflozin (Drug); Dapagliflozin matched placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7 |
-12.87; -13.15 | — |
| PRIMARY Change From Baseline in Plasma Concentration (Cmax) on Day 7 |
17.52; 15.26; 25.28; 25.61; 18.45; 18.42 | — |
| PRIMARY Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7 |
149.1; 141.0; 212.7; 221.3; 174.2; 176.5 | — |
| PRIMARY Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7 |
149.0; 140.9; 212.6; 221.1; 174.1; 176.3 | — |
| SECONDARY Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7 |
-327.161; -264.851 | — |
| SECONDARY Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7 |
4.00; 4.00; 4.00; 4.00; 4.00; 4.00 | — |
| SECONDARY Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7 |
24.00; 24.00; 24.00; 24.00; 24.00; 24.00 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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* 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.
Data sourced from ClinicalTrials.gov (NCT03316131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.