RDEA3170 Tablet and Capsule Bioavailability Study
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/22/2018 |
Start Date: | May 1, 2015 |
End Date: | January 29, 2016 |
A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules
compared with RDEA3170 tablets.
compared with RDEA3170 tablets.
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.
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