Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-10

Study Completion Date

2019-08-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Ability of Functional Magnetic Resonance Imaging (fMRI) to Detect and Characterize the Effects of Two Marketed Centrally Active Drugs, Placebo, and RO4917523 in Healthy Volunteers

NCT01045083

Healthy Volunteer

COMPLETED PHASE1

A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants

NCT02560142

Healthy Volunteer

COMPLETED

Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

NCT00388414

Low Back Pain

COMPLETED NA

Functional Brain Imaging in Healthy Volunteers to Study Cognitive Functions

NCT01974427

Healthy Volunteers

COMPLETED

To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

NCT01173757

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 mg ITI-214

Single dose

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

10 mg ITI-214

Single dose

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

Placebo

Single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ITI-214

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male or female, 18 - 45 years
* Fluent and literate in English and able to provide written informed consent
* BMI between 18.5 and 38.0 kg/m2 and minimum body weight of 50 kg

Exclusion Criteria

* Recent exposure to any investigational product
* Previous exposure to relevant fMRI task(s)
* Considered medically unsuitable for participation
* Has any contraindication for BOLD fMRI

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes