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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03489772

Run by

Intra-Cellular Therapies, Inc.

People needed

26

Starts

2018-07-10

Expected to finish

2019-08-05

Last updated by the study team

2019-11-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Laureate Institute for Brain Research, Inc. — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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