Clinical trial NCT01744379: Single and Multiple Dose Study in Japanese
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Incidence of Adverse Events and Changes in Laboratory Parameters
timeFrame: 5 to 6 weeks
measure: Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2.
timeFrame: Day -1 through 12
measure: Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion.
timeFrame: Day 1 through 12
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S Bradley, MD
role: STUDY_DIRECTOR
References: