Expired Study
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Austin, Texas 78744


Purpose:

The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.


Criteria:

Inclusion Criteria: - Subject is able to understand the study procedures and the risks involved, and is willing to provide written informed consent before the first study-related activity. - Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. - Subject has a Screening serum urate level of 4 to 7 mg/dL. - Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment. Exclusion Criteria: - Subject has a history or suspicion of kidney stones. - Subject has undergone major surgery within 3 months prior to Screening. - Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1. - Subject has clinically unacceptable physical examination, per the Investigator's judgment. - Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment. - Subject has Screening clinical safety laboratory parameters (serum chemistry [other than serum creatinine and serum urate], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator. - Subject has a serum creatinine value above the upper limit of normal at the Screening visit. - Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment. - Subject has a history of cardiac abnormalities - Subject cannot swallow multiple tablets or capsules. - Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.


NCT ID:

NCT02448368


Primary Contact:

Study Director
J Hall, MD
Ardea Biosciences, Inc.


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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