At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
TAK-831drug
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 Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-831 for Healthy Volunteers. Completed, enrolled 15 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsTakeda
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartApr 2017
First PostedApr 2017
Primary CompletionMay 2017
Study CompletionMay 2017
TodayJul 2026
First PostedApr 5, 2017
Enrollment StartApr 4, 2017
Primary CompletionMay 19, 2017
Study CompletionMay 26, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago
Interventions
TAK-831drug
TAK-831 film-coated tablet.