Single and Multiple Dose Study in Japanese Subjects

NCT01872832 | Completed Phase 1

• 1 other identifier: RDEA3170-104
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters

  5 to 6 weeks

• 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

• 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

Study Arms (4)

5 mg RDEA3170

EXPERIMENTAL

RDEA3170 5 mg or placebo fasted and fed

Drug: RDEA3170 and Placebo

10 mg RDEA3170

EXPERIMENTAL

RDEA3170 10 mg or placebo fasted and fed

Drug: RDEA3170 and Placebo

15 mg RDEA3170

EXPERIMENTAL

RDEA3170 15 mg or placebo fasted and fed

Drug: RDEA3170 and Placebo

2.5 mg RDEA3170

EXPERIMENTAL

RDEA3170 2.5 mg or placebo fasted and fed

Drug: RDEA3170 and Placebo

Interventions

RDEA3170 and Placebo DRUG

10 mg RDEA3170; 15 mg RDEA3170; 2.5 mg RDEA3170; 5 mg RDEA3170

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (1)

Unknown Facility

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Gout

Interventions

verinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• S Baumgartner, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 7, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

US (1)