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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

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
GroupInterventionDescription
Single DoseRDEA3170 4.5 mgSingle dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Single DoseRDEA3170 6 mgSingle dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Single DoseRDEA3170 12 mgSingle dose of RDEA3170 4.5 mg, RDEA3170 6 mg or RDEA3170 12 mg on Days 1, 5 and 9.
Multiple DoseRDEA3170 12 mgRDEA3170 12 mg once daily (qd)
Single Dose Food EffectRDEA3170 6 mgSince dose of RDEA3170 6 mg administered in fed or fasted state on Day 1 and Day 8.
Primary Outcome Measures
NameTimeMethod
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 amountDays -1, 1, 7 and 8

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

Renal clearance of uric acidDays -1, 1 and 7

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

Fractional excretion of uric acidDays -1, 1, 7 and 8

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

Renal Clearance of Uric AcidDays -1, 1, 7 and 8

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

CmaxDays -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

AUCDays -1, 1, 7 and 8

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

TmaxDays -1, 1, 7 and 8

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

Serum urate concentrationDays -1, 1, 7 and 8

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

Secondary Outcome Measures
NameTimeMethod
Incidence of Adverse Events in terms of vital signs6 weeks
Incidence of Adverse Events in terms of changes in laboratory parameters6 weeks
Incidence of Adverse Events in terms of electrocardiogram parameters6 weeks
Incidence of Adverse Events in terms of physical examination findings6 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

t1/2Days -1, 1 and 7

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

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