RDEA3170 PK/PD Study

Study Overview
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Brief Summary
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The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses

Official Title
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A Phase 1, Randomized, Open-Label Study in Healthy Adult Male Subjects to Assess the Pharmacokinetics and Pharmacodynamics of RDEA3170

Conditions
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Gout

Intervention / Treatment
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* Drug: RDEA3170 4.5 mg
* Drug: RDEA3170 6 mg
* Drug: RDEA3170 12 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. Subject has a Screening serum urate level 4 to 7 mg/dL Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment. Exclusion Criteria: Subject has a history or suspicion of kidney stones. Subject has undergone major surgery within 3 months prior to Screening. Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1. Subject has clinically unacceptable physical examination, per the Investigator's judgment. Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment. Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator. Subject has a serum creatinine value above the upper limit of normal at the Screening visit. Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment. Subject has a history of cardiac abnormalities Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose<br>Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9. | Drug: RDEA3170 4.5 mg<br> <br> Drug: RDEA3170 6 mg<br> <br> Drug: RDEA3170 12 mg<br> <br> |
| Experimental: Multiple Dose<br>RDEA3170 12 mg once daily (qd) | Drug: RDEA3170 12 mg<br> <br> |
| Experimental: Single Dose Food Effect<br>Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8. | Drug: RDEA3170 6 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed concentration (Cmax) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Cmax | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| Cmax | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| Time of Occurrence of maximum observed concentration (Tmax) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Area under the plasma concentration time curve (AUC) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Tmax | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| AUC | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| Tmax | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| AUC | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| Serum urate concentration | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Urine uric acid excretion amount | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Renal clearance of uric acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Fractional excretion of uric acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg | Days -1, 1, 5 and 9 | 
| Serum urate concentration | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| Urine uric acid excretion amount | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| Renal clearance of uric acid | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| Fractional excretion of uric acid | Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg | Days -1, 1 and 7 | 
| Serum urate concentration | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| Urine uric acid excretion amount | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| Renal Clearance of Uric Acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| Fractional excretion of uric acid | Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events in terms of changes in laboratory parameters |  | 6 weeks | 
| Incidence of Adverse Events in terms of electrocardiogram parameters |  | 6 weeks | 
| Incidence of Adverse Events in terms of vital signs |  | 6 weeks | 
| Incidence of Adverse Events in terms of physical examination findings |  | 6 weeks | 
| Apparent terminal half-life (t1/2) | Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine | Days -1, 1, 5 and 9 | 
| t1/2 | Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions | Days -1, 1, 7 and 8 | 
| t1/2 | Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine | Days -1, 1 and 7 |