Healthy VolunteersPhase 1NCT03489772
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
A Phase 1 study testing ITI-214 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ITI-214
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 5 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research, Inc.
Tulsa, Oklahoma, 74136
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- ITI-214, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITI-214Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 mg ITI-214 | Experimental | Single dose Receives: Drug: ITI-214 |
| 10 mg ITI-214 | Experimental | Single dose Receives: Drug: ITI-214 |
| Placebo | Placebo comparator | Single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
Changes in brain activation
Measured: 1-3 hours post-dose
BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task
Changes in brain activation
Measured: 1-3 hours post-dose
Secondary outcomes (3)
BOLD fMRI signals elicited by fear conditioning stimulus
Changes in brain activation in amygdala, prefrontal cortex, and/or insula cortex
Measured: 1-3 hours post-dose
BOLD fMRI signals elicited by the Stop versus Go signal
Changes in brain activation in dorsolateral prefrontal cortex and/or anterior cingulate cortex
Measured: 1-3 hours post-dose
Number of subjects with reported or observed treatment-related adverse events
Safety and tolerability
Measured: 0-5 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start10 Jul 2018
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Intra-Cellular Therapies, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laureate Institute for Brain Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Davis, PhD, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489772
- Sponsor's protocol ID
- ITI-214-106
- Status last verified
- Nov 2019
- First submitted
- 9 Mar 2018
- Last updated
- 6 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 35488084
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03489772
- Acronym / sponsor ID
- ITI-214-106
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Intra-Cellular Therapies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laureate Institute for Brain Research, Inc.
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 mg ITI-214 | Experimental | Drug: ITI-214Single dose |
| 10 mg ITI-214 | Experimental | Drug: ITI-214Single dose |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Recent exposure to any investigational product
- Previous exposure to relevant fMRI task(s)
- Considered medically unsuitable for participation
- Has any contraindication for BOLD fMRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITI-214Oral | Drug | 1 mg ITI-214, 10 mg ITI-214 |
| PlaceboOral | Drug | Placebo |
Primary outcome
BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task
Time frame: 1-3 hours post-dose
Changes in brain activation
BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task
Time frame: 1-3 hours post-dose
Changes in brain activation
3 secondary outcomes
BOLD fMRI signals elicited by fear conditioning stimulus
Time frame: 1-3 hours post-dose
BOLD fMRI signals elicited by the Stop versus Go signal
Time frame: 1-3 hours post-dose
Number of subjects with reported or observed treatment-related adverse events
Time frame: 0-5 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Derived from this study: PubMed 35488084Khalsa 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.
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Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Davis, PhD study director
Intra-Cellular Therapies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ITI-214 in people with Healthy Volunteers, run by Intra-Cellular Therapies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task (time frame: 1-3 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.