Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/28/2018 |
| Start Date: | July 10, 2018 |
| End Date: | June 2019 |
| Contact: | Robert Davis, PhD |
| Email: | itciclinicaltrials@intracellulartherapies.com |
| Phone: | 646-440-9333 |
A Randomized, Placebo-Controlled, Double-Blind Study of Escalating Single Doses of ITI-214 in Healthy Volunteers to Determine Central Nervous System Engagement, Safety and Tolerability
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.
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.
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
We found this trial at
1
site
Tulsa, Oklahoma 74136
Principal Investigator: Sahib S Khalsa, MD, PhD
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