RDEA3170 PK/PD Study

Phase 1

Completed

• Conditions: Gout
• Interventions: Drug: RDEA3170 4.5 mg; Drug: RDEA3170 6 mg; Drug: RDEA3170 12 mg

• Registration Number: NCT02608710
• Lead Sponsor: Ardea Biosciences, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-15
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Dose	RDEA3170 4.5 mg	Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Single Dose	RDEA3170 6 mg	Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Single Dose	RDEA3170 12 mg	Single dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Multiple Dose	RDEA3170 12 mg	RDEA3170 12 mg once daily (qd)
Single Dose Food Effect	RDEA3170 6 mg	Since dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.

Primary Outcome Measures

Name	Time	Method
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
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 and 7	Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg
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
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
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
AUC	Days -1, 1, 7 and 8	Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions
Tmax	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, 7 and 8	Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events in terms of vital signs	6 weeks
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 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 and 7	Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine