RDEA3170 and Febuxostat Drug Interaction Study

Study Overview
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Brief Summary
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This study will evaluate the potential pharmacokinetic (PK) and pharmacodynamic (PD) interaction between the XO inhibitor febuxostat and the investigational URAT1 inhibitor RDEA3170 and provide information for potential future clinical studies using this combination. Combination treatment using 2 drugs with different mechanisms of action may achieve improved response and may allow the use of lower doses, resulting in fewer side effects than the use of either drug alone.

Official Title
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A Phase 1 Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Febuxostat in Healthy Adult Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: RDEA3170 10 mg
* Drug: Febuxostat 40 mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values, per the Investigator's judgment. a screening serum urate level ≥ 4.5 mg/dL. Exclusion Criteria: history or suspicion of kidney stones. history of cardiac abnormalities as assessed during screening, including abnormal and clinically relevant electrocardiogram changes and/or family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years. undergone major surgery within 3 months prior to Day 1. donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening Period. inadequate venous access or unsuitable veins for repeated venipuncture.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Febuxostat<br>Days 1-7: febuxostat 40 mg qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd. Days 15-21: RDEA3170 10 mg or placebo qd. | Drug: RDEA3170 10 mg<br>* RDEA3170 10 mg once daily (qd)<br>Drug: Febuxostat 40 mg<br>* Febuxostat 40 mg qd<br>Drug: placebo<br>* placebo qd<br>|
| Experimental: RDEA3170<br>Days 1-7: RDEA3170 10 mg or placebo qd. Days 8-14: RDEA3170 10 mg or placebo qd in combination with febuxostat 40 mg qd. Days 15-21: febuxostat 40 mg qd. | Drug: RDEA3170 10 mg<br>* RDEA3170 10 mg once daily (qd)<br>Drug: Febuxostat 40 mg<br>* Febuxostat 40 mg qd<br>Drug: placebo<br>* placebo qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of RDEA3170 from plasma and urine and febuxostat from plasma | Profile from plasma and urine in terms of AUC, Tmax, Cmax, t1/2, Ae, and CLr AUC: area under the concentration-time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life; Ae: amount excreted of unchanged drug into urine; CLr: renal clearance | Days -1 (urine only), 7, 14, 21 and Days 8, 15, 22 (plasma only) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD profile of RDEA3170 and febuxostat alone and in combination | Profile from serum and urine in terms of sUA concentration, renal clearance of uric acid, urine uric acid excretion amounts, and fractional excretion of uric acid. sUA: serum urate | Days -1, 7, 14, 21 and Days 8, 15, 22 (serum only) | 
| Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters |  | 8 weeks |