RDEA3170 PK/PD Study

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

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

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: RDEA3170 4.5 mg; Drug: RDEA3170 6 mg; Drug: RDEA3170 12 mg

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ardea Biosciences, Inc.
• Investigators: Study Director: J. Hall, MD, Ardea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 15, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Verinurad
• Other Study ID Numbers: RDEA3170-112