NCT02448368

RDEA3170 Tablet and Capsule Bioavailability Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RDEA3170,10 mg	Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
DRUG	RDEA3170, 2.5 mg	Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
DRUG	RDEA3170, 5 mg	Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
DRUG	RDEA3170, 10 mg	Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
DRUG	RDEA3170, 2.5 mg	Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-06-26
• Completion: 2016-01-29
• First posted: 2015-05-19
• Last updated: 2018-08-20
• Results posted: 2018-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study