CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
TAK-831 T2 +1 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.

Search/NCT03706469
NCT03706469Phase 1Completed

A Phase 1, Open-Label, Randomized, Single Dose, 5-Period, 5-Treatment Study to Evaluate the Relative Bioavailability and Effect of Food on TAK-831 Tablet Formulations in Healthy Subjects

Neurocrine Biosciences·interventional·Posted Oct 16, 2018·Updated Jun 14, 2021

In Brief

A Phase 1 clinical trial evaluating TAK-831 T2 and TAK-831 T3 for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedOct 16, 2018
Enrollment StartOct 18, 2018
Primary CompletionDec 11, 2018
Study CompletionDec 22, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.7 years ago

Interventions

TAK-831 T2drug

TAK-831 T2 Tablets.

TAK-831 T3drug

TAK-831 T3 Tablets.