CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
TAK-831 +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/NCT03687684
NCT03687684Phase 1Completed

Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK 831 in Healthy Adult Asian Subjects

Neurocrine Biosciences·interventional·Posted Sep 27, 2018·Updated Jun 14, 2021

In Brief

A Phase 1 clinical trial evaluating TAK-831 and Placebo for Healthy Volunteers. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
CollaboratorsTakeda

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 27, 2018
Enrollment StartOct 9, 2018
Primary CompletionJun 9, 2019
Study CompletionJun 19, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.8 years ago

Interventions

TAK-831drug

TAK-831 Tablets.

Placebodrug

TAK-831 Matching Placebo Tablets.