NCT01744379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

November 29, 2012

Last Update Submit

June 18, 2013

Conditions

Gout

Outcome Measures

Primary Outcomes (3)

  • Incidence of Adverse Events and Changes in Laboratory Parameters

    5 to 6 weeks

  • Pharmacokinetic (PK) profile of lesinurad from plasma and urine in terms of AUC, tmax, cmax and t1/2.

    AUC: area under the plasma concentration time curve from zero to 24 hours post dose and from zero to infinity; tmax: time to maximum plasma concentration; cmax: maximum observed plasma concentration t1/2: terminal elimination half life

    Day -1 through 12

  • Pharmacodynamic (PD) profile of lesinurad from serum and urine in terms of sUA concentration, renal clearance, urine uric acid excretion, and fractional excretion.

    Day 1 through 12

Study Arms (5)

200 mg lesinurad

EXPERIMENTAL

200 mg lesinurad or placebo fasted and fed

Drug: LesinuradDrug: Placebo

400 mg lesinurad

EXPERIMENTAL

400 mg lesinurad or placebo fasted and fed

Drug: LesinuradDrug: Placebo

100 mg lesinurad

EXPERIMENTAL

100 mg lesinurad or placebo fasted and fed

Drug: LesinuradDrug: Placebo

50 mg lesinurad

EXPERIMENTAL

50 mg lesinurad or placebo fasted and fed

Drug: LesinuradDrug: Placebo

600 mg lesinurad

EXPERIMENTAL

600 mg lesinurad or placebo fasted and fed

Drug: LesinuradDrug: Placebo

Interventions

LesinuradDRUG
100 mg lesinurad200 mg lesinurad400 mg lesinurad50 mg lesinurad600 mg lesinurad
PlaceboDRUG
100 mg lesinurad200 mg lesinurad400 mg lesinurad50 mg lesinurad600 mg lesinurad

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Gout

Interventions

lesinurad

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • S Bradley, MD

    Ardea Biosciences, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 6, 2012

Study Start

December 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)