Gout and Asymptomatic Hyperuricemia Clinical Trial
Official title:
A Phase 2a, Randomized, Open-Label, Single-Site Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to RDEA3170 Administered Alone and Febuxostat Administered Alone, Respectively in Japanese Adult Male Subjects With Gout or Asymptomatic Hyperuricemia
| Verified date | June 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.
| Status | Completed |
| Enrollment | 110 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Screening serum uric acid level = 8 mg/dL; - Body weight = 50 kg and a body mass index (BMI) = 18 and = 40 kg/m2; - Free of any clinically significant disease or medical condition, per the Investigator's judgment. Exclusion Criteria: - History or suspicion of kidney stones; - Diagnosis of benign prostatic hypertrophy (BPH) or neurogenic bladder or evidence of BPH/neurogenic bladder such as thin urinary stream or difficulty in urination; - An estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula; - QTcF interval (QT interval corrected for heart rate using Fridericia's formula) > 450 msec at Screening; - Receiving strong or moderate Cytochrome P450 (CYP) 3A inhibitors or p-glycoprotein inhibitors, or digoxin |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Fukuoka-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Ardea Biosciences, Inc. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in Urinary pH | To evaluate the relationship between the doses of uralyt and urinary pH under the administration of RDEA3170. | baseline and day 7 on each treatment | |
| Other | Deoxyribonucleic acid polymorphism | To collect and store deoxyribonucleic acid (DNA) for future exploratory research. | Day 1 of the study as randomization | |
| Other | Change in Serum uric acid level | % change per treatment will be compared. | Baseline and day 7 on each treatment for cohort 6 | |
| Other | Change in Urinary excretion of uric acid | Timed urinary uric acid excretion per treatment will be compared. | Baseline and day 7 on each treatment for cohort 6 | |
| Other | Renal clearance of uric acid | Renal clearance of uric acid will be calculated. | Baseline and day 7 on each treatment for cohort 6 | |
| Other | Fractional excretion of uric acid | Fractional excretion and renal clearance of uric acid will be calculated. | Baseline and day 7 on each treatment for cohort 6 | |
| Primary | Change in Serum uric acid level | % change per treatment will be compared. | baseline and day 7 on each treatment | |
| Primary | Change in Urinary excretion of uric acid | Timed urinary uric acid excretion per treatment will be compared | baseline and day 7 on each treatment | |
| Primary | Renal clearance of uric acid | Renal clearance of uric acid will be calculated. | baseline and day 7 on each treatment | |
| Primary | Fractional excretion of uric acid | Fractional excretion and renal clearance of uric acid will be calculated. | baseline and day 7 on each treatment | |
| Secondary | Maximum plasma concentration (Cmax) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | |
| Secondary | Time to reach maximum concentration (tmax) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | |
| Secondary | Area under the concentration-time curve (AUC) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | |
| Secondary | Half life (t1/2) | To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment. | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment | |
| Secondary | Incidence of adverse events | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 1 and Day 7 on each treatment | |
| Secondary | Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 1 and Day 8 on each treatment | |
| Secondary | Changes in vital signs and physical examination findings | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 1 and Day 8 on each treatment | |
| Secondary | Incidence of adverse events | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 42 of the study as follow up | |
| Secondary | Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 42 of the study as follow up | |
| Secondary | Changes in vital signs and physical examination findings | To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170 | Day 42 of the study as follow up |