Single and Multiple Dose Study in Japanese

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01744379
First received: November 29, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Gout
Drug: Lesinurad
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of Lesinurad in Healthy Male Japanese Subjects

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

Primary Outcome Measures:
  • Incidence of Adverse Events and Changes in Laboratory Parameters [ Time Frame: 5 to 6 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2. [ Time Frame: Day -1 through 12 ] [ Designated as safety issue: No ]
    AUC: area under the plasma concentration time curve from zero to 24 hours post dose and from zero to infinity; tmax: time to maximum plasma concentration; cmax: maximum observed plasma concentration t1/2: terminal elimination half life

  • Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion. [ Time Frame: Day 1 through 12 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 mg lesinurad
200 mg lesinurad or placebo fasted and fed
Drug: Lesinurad Drug: Placebo
Experimental: 400 mg lesinurad
400 mg lesinurad or placebo fasted and fed
Drug: Lesinurad Drug: Placebo
Experimental: 100 mg lesinurad
100 mg lesinurad or placebo fasted and fed
Drug: Lesinurad Drug: Placebo
Experimental: 50 mg lesinurad
50 mg lesinurad or placebo fasted and fed
Drug: Lesinurad Drug: Placebo
Experimental: 600 mg lesinurad
600 mg lesinurad or placebo fasted and fed
Drug: Lesinurad Drug: Placebo

Detailed Description:

While there is extensive clinical experience with lesinurad in the 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 lesinurad 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, the risks involved and willing to provide written Informed Consent before the first study related activity.
  • Healthy adult subjects born in Japan
  • All laboratory parameters should be within normal limits or considered not clinically significant by the investigator.
  • Screening serum uric acid level >= 4.5 mg/dL.
  • Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
  • Subject does not have clinically relevant abnormalities in blood pressure, heart rate, body temperature, and respiratory rate, as per the Investigator's judgment.

Exclusion Criteria:

  • Positive serology to Human Immunodeficiency Virus (HIV-1 and HIV-2).
  • Positive test for active Hepatitis B or Hepatitis C infection.
  • History of kidney stones.
  • Undergone major surgery within 3 months of Day 1.
  • Subject has received the last dose of an investigational drug (or treatment with a medical device) within 30 days or 5 half-lives (whichever is longer) of the investigational drug prior to Day 1 or are currently participating in another study of an investigational drug (or medical device).
  • Prior exposure to lesinurad (RDEA594) or RDEA806.
  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: NCT01744379

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

No publications provided

Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01744379     History of Changes
Other Study ID Numbers: RDEA594-125
Study First Received: November 29, 2012
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 22, 2014