RDEA3170 Tablet and Capsule Bioavailability Study

• Status: Completed
• Trial end date: 2016-01-29
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Verinurad

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.