RDEA3170 Tablet and Capsule Bioavailability Study
Completed · Phase 1
Conditions studied: Healthy
In brief
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
Key facts
- Study ID
- NCT02448368
- Run by
- Ardea Biosciences, Inc.
- People needed
- 35
- Starts
- 2015-05-01
- Expected to finish
- 2016-01-29
- Last updated by the study team
- 2018-08-20
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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