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

Intra-Cellular Therapies

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ITI-214; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03489772

ITI-214-106

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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26 participants in 3 patient groups, including a placebo group

1 mg ITI-214

Experimental group

Description:

Single dose

Treatment:

Drug: ITI-214

10 mg ITI-214

Experimental group

Description:

Single dose

Treatment:

Drug: ITI-214

Placebo

Placebo Comparator group

Description:

Single dose

Treatment:

Drug: Placebo