Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
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
1 other identifier
interventional
26
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jul 2018
Longer than P75 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 5, 2018
CompletedStudy Start
First participant enrolled
July 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2019
CompletedNovember 6, 2019
November 1, 2019
1.1 years
March 9, 2018
November 5, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
Changes in brain activation
1-3 hours post-dose
BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task
Changes in brain activation
1-3 hours post-dose
Secondary Outcomes (3)
BOLD fMRI signals elicited by fear conditioning stimulus
1-3 hours post-dose
BOLD fMRI signals elicited by the Stop versus Go signal
1-3 hours post-dose
Number of subjects with reported or observed treatment-related adverse events
0-5 hours post-dose
Other Outcomes (1)
BOLD fMRI signals elicited in the amygdala, insula and medial prefrontal cortex
1-3 hours post-dose
Study Arms (3)
1 mg ITI-214
EXPERIMENTALSingle dose
10 mg ITI-214
EXPERIMENTALSingle dose
Placebo
PLACEBO COMPARATORSingle dose
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laureate Institute for Brain Research, Inc.
Tulsa, Oklahoma, 74136, United States
Related Publications (1)
Khalsa SS, Victor TA, Kuplicki R, Yeh HW, Vanover KE, Paulus MP, Davis RE. Single doses of a highly selective inhibitor of phosphodiesterase 1 (lenrispodun) in healthy volunteers: a randomized pharmaco-fMRI clinical trial. Neuropsychopharmacology. 2022 Sep;47(10):1844-1853. doi: 10.1038/s41386-022-01331-3. Epub 2022 Apr 29.
PMID: 35488084DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Robert Davis, PhD
Intra-Cellular Therapies, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2018
First Posted
April 5, 2018
Study Start
July 10, 2018
Primary Completion
August 5, 2019
Study Completion
August 5, 2019
Last Updated
November 6, 2019
Record last verified: 2019-11