CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
RDEA3170,10 mg +4 moredrug
Likely dose
RDEA3170,10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02448368
NCT02448368Phase 1Completed
CompareCT.gov

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

Ardea Biosciences, Inc.·interventional·Posted May 19, 2015·Updated Aug 20, 2018

In Brief

A Phase 1 clinical trial evaluating RDEA3170,10 mg, RDEA3170, 2.5 mg, and 2 other interventions for Healthy. Completed, enrolled 35 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 19, 2015
Enrollment StartMay 1, 2015
Primary CompletionJun 26, 2015
Study CompletionJan 29, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.1 years ago

Interventions

RDEA3170,10 mgdrug

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

RDEA3170, 2.5 mgdrug

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

RDEA3170, 5 mgdrug

Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.

RDEA3170, 10 mgdrug

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.

RDEA3170, 2.5 mgdrug

Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.