Single and Multiple Dose Study in Japanese

Ardea Biosciences

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: Lesinurad; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01744379

RDEA594-125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 5 patient groups

200 mg lesinurad

Experimental group

Description:

200 mg lesinurad or placebo fasted and fed

Treatment:

Drug: Lesinurad

Drug: Placebo

400 mg lesinurad

Experimental group

Description:

400 mg lesinurad or placebo fasted and fed

Treatment:

Drug: Lesinurad

Drug: Placebo

100 mg lesinurad

Experimental group

Description:

100 mg lesinurad or placebo fasted and fed

Treatment:

Drug: Lesinurad

Drug: Placebo

50 mg lesinurad

Experimental group

Description:

50 mg lesinurad or placebo fasted and fed

Treatment:

Drug: Lesinurad

Drug: Placebo

600 mg lesinurad

Experimental group

Description:

600 mg lesinurad or placebo fasted and fed

Treatment:

Drug: Lesinurad

Drug: Placebo