RDEA3170 PK/PD Study
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the pharmacokinetic and pharmacodynamic effect of RDEA3170 when given as single or multiple doses
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Dose 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
Drug: RDEA3170 6 mg
Drug: RDEA3170 12 mg
|
| Experimental: Multiple Dose RDEA3170 12 mg once daily (qd) |
Drug: RDEA3170 12 mg
|
| Experimental: Single Dose Food Effect Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8. |
Drug: RDEA3170 6 mg
|
Outcome Measures
Primary Outcome Measures
- Maximum observed concentration (Cmax) [Days -1, 1, 5 and 9]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Cmax [Days -1, 1 and 7]
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
- Cmax [Days -1, 1, 7 and 8]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
- Time of Occurrence of maximum observed concentration (Tmax) [Days -1, 1, 5 and 9]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Area under the plasma concentration time curve (AUC) [Days -1, 1, 5 and 9]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Tmax [Days -1, 1 and 7]
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
- AUC [Days -1, 1 and 7]
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg
- Tmax [Days -1, 1, 7 and 8]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
- AUC [Days -1, 1, 7 and 8]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
- Serum urate concentration [Days -1, 1, 5 and 9]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Urine uric acid excretion amount [Days -1, 1, 5 and 9]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Renal clearance of uric acid [Days -1, 1, 5 and 9]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Fractional excretion of uric acid [Days -1, 1, 5 and 9]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg
- Serum urate concentration [Days -1, 1 and 7]
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
- Urine uric acid excretion amount [Days -1, 1 and 7]
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
- Renal clearance of uric acid [Days -1, 1 and 7]
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
- Fractional excretion of uric acid [Days -1, 1 and 7]
Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
- Serum urate concentration [Days -1, 1, 7 and 8]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
- Urine uric acid excretion amount [Days -1, 1, 7 and 8]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
- Renal Clearance of Uric Acid [Days -1, 1, 7 and 8]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
- Fractional excretion of uric acid [Days -1, 1, 7 and 8]
Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions
Secondary Outcome Measures
- 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) [Days -1, 1, 5 and 9]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg from plasma and urine
- t1/2 [Days -1, 1, 7 and 8]
Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
- t1/2 [Days -1, 1 and 7]
Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Ardea Biosciences, Inc.
Investigators
- Study Director: J. Hall, MD, Ardea Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RDEA3170-112