Recruitment

Recruitment Status
Completed
Estimated Enrollment
48

Inclusion Criterias

Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
Subject has a normal or clinically acceptable physical examination.
Subject is in possession of a valid Japanese passport.
...
Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
Subject has a normal or clinically acceptable physical examination.
Subject is in possession of a valid Japanese passport.
Healthy adult male subject born in Japan.
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 has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.
Subject has parents and grandparents who are Japanese.
Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.

Exclusion Criterias

Positive test for active hepatitis B or hepatitis C infection.
Undergone major surgery within 3 months prior to Day 1.
Prior exposure to RDEA3170.
...
Positive test for active hepatitis B or hepatitis C infection.
Undergone major surgery within 3 months prior to Day 1.
Prior exposure to RDEA3170.
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).
History or suspicion of kidney stones.
Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).

Summary

Conditions
Gout
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 55 years
Gender
Only males

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, pharmac...

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.

Inclusion Criterias

Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
Subject has a normal or clinically acceptable physical examination.
Subject is in possession of a valid Japanese passport.
...
Able to understand the study procedures and the risks involved, and willing to provide written informed consent before the first study related activity.
Subject has a normal or clinically acceptable physical examination.
Subject is in possession of a valid Japanese passport.
Healthy adult male subject born in Japan.
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 has no clinically relevant abnormalities in blood pressure, heart rate, and body temperature, per the Investigator's judgment.
Subject has parents and grandparents who are Japanese.
Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.

Exclusion Criterias

Positive test for active hepatitis B or hepatitis C infection.
Undergone major surgery within 3 months prior to Day 1.
Prior exposure to RDEA3170.
...
Positive test for active hepatitis B or hepatitis C infection.
Undergone major surgery within 3 months prior to Day 1.
Prior exposure to RDEA3170.
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).
History or suspicion of kidney stones.
Positive serology to human immunodeficiency virus (HIV-1 or HIV-2).

Locations

Glendale, California, 91206
Glendale, California, 91206

Tracking Information

NCT #
NCT01872832
Collaborators
Not Provided
Investigators
Study Director: S Baumgartner, MD Ardea Biosciences, Inc.