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Single and Multiple Dose Study in Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01872832
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gout Drug: RDEA3170 and Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

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

Primary Outcome Measures :
  1. Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 to 6 weeks ]
  2. PK profile of RDEA3170 from plasma and urine [ Time Frame: Day 1 through 15 ]

    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

  3. PD profile of RDEA3170 from serum and urine [ Time Frame: Day 1 through 15 ]

    Profile in terms of sUA concentration; CLr; urine uric acid excretion amount; fractional excretion of uric acid

    sUA: serume urate; CLr: renal clearance

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01872832

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United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Ardea Biosciences, Inc.
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Study Director: S Baumgartner, MD Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc. Identifier: NCT01872832    
Other Study ID Numbers: RDEA3170-104
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Gout Suppressants
Antirheumatic Agents