At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
TAK-385 T2 Formulation +2 moredrug
Likely dose
Not stated in 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.
A Phase 1, Open-Label, Randomized, Three-Way Crossover Study Evaluating the Relative Bioavailability and Effect of Food on TAK-385 Tablet Formulations in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-385 T2 Formulation, TAK-385 T4 Formulation B, and 1 other intervention for Healthy Volunteers. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the oral bioavailability of two new tablet formulations of TAK-385 (T4 Formulation B and T4 Formulation C) under fasted and fed conditions, relative the T2 Formulation tablet; and to estimate the effect of food on the pharmacokinetics (PK) of a single oral dose of the T4 Formulation B tablet and the T4 Formulation C tablet.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartMar 2015
First PostedMar 2015
Primary CompletionApr 2015
Study CompletionJun 2015
TodayJul 2026
First PostedMar 24, 2015
Enrollment StartMar 1, 2015
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.3 years ago
Interventions
TAK-385 T2 Formulationdrug
TAK-385 T2 Formulation tablets
TAK-385 T4 Formulation Bdrug
TAK-385 T4 Formulation B tablets
TAK-385 T4 Formulation Cdrug
TAK-385 T4 Formulation C tablets