Single and Multiple Dose Study in Japanese Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01872832
First received: June 3, 2013
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Gout
Drug: RDEA3170 and Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Ardea Biosciences, Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters [ Time Frame: 5 to 6 weeks ] [ Designated as safety issue: Yes ]
  • PK profile of RDEA3170 from plasma and urine [ Time Frame: Day 1 through 15 ] [ Designated as safety issue: No ]

    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


  • PD profile of RDEA3170 from serum and urine [ Time Frame: Day 1 through 15 ] [ Designated as safety issue: No ]

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

    sUA: serume urate; CLr: renal clearance



Enrollment: 46
Study Start Date: June 2013
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872832

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

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01872832     History of Changes
Other Study ID Numbers: RDEA3170-104
Study First Received: June 3, 2013
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014