Single and Multiple Dose Study in Japanese Subjects

A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of RDEA3170 in Healthy Male Japanese Subjects

This study will explore the safety, tolerability, and serum uric acid lowering effect of RDEA3170 in healthy Japanese males to allow comparison with the Western population.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: RDEA3170 and Placebo

Detailed Description

While clinical studies of RDEA3170 to date have been limited to a Western population, it is recognized that both intrinsic and extrinsic factors may impact the PK, PD, safety, and dose response in different ethnic populations. The purpose of this study is to explore the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of single and multiple doses of RDEA3170 in healthy Japanese males, and to allow comparison of these parameters with the Western population.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
• Healthy adult male subject born in Japan.
• Subject has parents and grandparents who are Japanese.
• Subject is in possession of a valid Japanese passport.
• All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
• Screening serum urate level ≥ 4.5 mg/dL.
• Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
• Subject has a normal or clinically acceptable physical examination.
• Subject has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.

Exclusion Criteria:

• Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).
• Positive test for active hepatitis B or hepatitis C infection.
• History or suspicion of kidney stones.
• Undergone major surgery within 3 months prior to Day 1.
• Exposed to an investigational drug (or a medical device) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to Day 1 or is currently participating in another study of an investigational drug (or medical device).
• Prior exposure to RDEA3170.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg RDEA3170; RDEA3170 5 mg or placebo fasted and fed	Drug: RDEA3170 and Placebo
Experimental: 10 mg RDEA3170; RDEA3170 10 mg or placebo fasted and fed	Drug: RDEA3170 and Placebo
Experimental: 15 mg RDEA3170; RDEA3170 15 mg or placebo fasted and fed	Drug: RDEA3170 and Placebo
Experimental: 2.5 mg RDEA3170; RDEA3170 2.5 mg or placebo fasted and fed	Drug: RDEA3170 and Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters		5 to 6 weeks
PK profile of RDEA3170 from plasma and urine	Profile in terms of AUC, Tmax, Cmax, and t1/2 AUC: area under the plasma concentration versus time curve; Tmax: time to maximum plasma concentration; Cmax: maximum plasma drug concentration; t1/2: apparent terminal half-life	Day 1 through 15
PD profile of RDEA3170 from serum and urine	Profile in terms of sUA concentration; CLr; urine uric acid excretion amount; fractional excretion of uric acid sUA: serume urate; CLr: renal clearance	Day 1 through 15

Collaborators and Investigators

• Sponsor: Ardea Biosciences, Inc.
• Investigators: Study Director: S Baumgartner, MD, Ardea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: June 3, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Verinurad
• Other Study ID Numbers: RDEA3170-104