RDEA3170 PK/PD Study

Ardea Biosciences, Inc.40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gout

Interventions

RDEA3170 4.5 mgDRUG

RDEA3170 6 mgDRUG

RDEA3170 12 mgDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Austin, Texas, United States

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax)

Single-dose Pharmacokinetic (PK) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

Time frame: Days -1, 1, 5 and 9

Cmax

Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

Cmax

Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

Time frame: 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

Time frame: 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

Time frame: Days -1, 1, 5 and 9

Tmax

Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

AUC

Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

Tmax

Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

Time frame: Days -1, 1, 7 and 8

AUC

Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

Data from ClinicalTrials.gov

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Time frame: Days -1, 1, 7 and 8

Serum urate concentration

Single-dose Pharmacodynamic (PD) profile of RDEA3170 4.5 mg, 6 mg and 12 mg

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Days -1, 1, 5 and 9

Serum urate concentration

Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

Urine uric acid excretion amount

Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

Renal clearance of uric acid

Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

Fractional excretion of uric acid

Multiple-dose Pharmacodynamic (PD) profile of RDEA3170 12 mg

Time frame: Days -1, 1 and 7

Serum urate concentration

Single-dose Pharmacodynamic (PD) profile of RDEA3170 6 mg under fed and fasted conditions

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Days -1, 1, 7 and 8

Secondary Outcomes

Incidence of Adverse Events in terms of changes in laboratory parameters

Time frame: 6 weeks

Incidence of Adverse Events in terms of electrocardiogram parameters

Time frame: 6 weeks

Incidence of Adverse Events in terms of vital signs

Time frame: 6 weeks

Incidence of Adverse Events in terms of physical examination findings

Time frame: 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

Time frame: Days -1, 1, 5 and 9

t1/2

Single-dose Pharmacokinetic (PK) profile of RDEA3170 6 mg under fed and fasted conditions

Time frame: Days -1, 1, 7 and 8

t1/2

Multiple-dose Pharmacokinetic (PK) profile of RDEA3170 12 mg from plasma and urine

Time frame: Days -1, 1 and 7