Single and Multiple Dose Study in Japanese Subjects

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872832
• Other study ID #: RDEA3170-104
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2013
• Last updated: January 8, 2014
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Ardea Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• RDEA3170 and Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ardea Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters		5 to 6 weeks	Yes
Primary	PK profile of RDEA3170 from plasma and urine	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	Day 1 through 15	No
Primary	PD profile of RDEA3170 from serum and urine	Profile in terms of sUA concentration; CLr; urine uric acid excretion amount; fractional excretion of uric acid; sUA: serume urate; CLr: renal clearance	Day 1 through 15	No