Clinical trial NCT01872832: Single and Multiple Dose Study in Japanese Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 46
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 RDEA3170 in healthy Japanese males to allow comparison with the Western population.

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 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.

Primary outcomes:
measure: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
timeFrame: 5 to 6 weeks
measure: PK profile of RDEA3170 from plasma and urine
timeFrame: Day 1 through 15
measure: PD profile of RDEA3170 from serum and urine
timeFrame: Day 1 through 15
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S Baumgartner, MD
role: STUDY_DIRECTOR
References: