CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 11 enrolled
Drug / intervention
TAK-935 +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/NCT02497235
NCT02497235Phase 1Completed

An Open-Label, Positron Emission Tomography, Phase 1 Study With [18F]MNI-792 to Determine Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935 After Single-Dose Oral Administration in Healthy Subjects.

Takeda·interventional·Posted Jul 14, 2015·Updated Apr 11, 2017

In Brief

A Phase 1 clinical trial evaluating TAK-935 and [18F]MNI-792 (tracer) for Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand \[18F\]MNI-792 and PET imaging and to determine the relationship of occupancy to TAK-935 exposure.

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 14, 2015
Enrollment StartJul 1, 2015
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.0 years ago

Interventions

TAK-935drug

TAK-935 oral solution.

[18F]MNI-792 (tracer)drug

\[18F\]MNI-792 injection.