Healthy ControlsPhase 1NCT02919774
Pomaglumetad Effects on Glutamate Biomarkers
A Phase 1 study testing POMA in people with Healthy Controls, run by New York State Psychiatric Institute at 4 sites in United States.
Trial summary
The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls
- What is being tested?
- POMA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2016to 25 May 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy
- Capable of understanding the study procedures and able to provide informed consent
- Men and women must agree to use a reliable method of birth control during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible
Who cannot join
- Current or past Axis I psychiatric history
- Positive urine toxicology
- History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated in prior research ketamine studies will be eligible. Subjects can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore subjects entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
- History of first-degree relative with schizophrenia
- History of violence
- Presence or positive history of significant medical illness
Show all 15Show fewer
- Presence or positive history neurological illness or any other disease/procedure/accident/intervention association with significant injury to or malfunction of the central nervous system (CNS) or history of significant head injury
- Pregnancy or breast feeding
- Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
- Medicinal patch, unless removed prior to MRI scan
- Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications and stimulants.
- Claustrophobia
- Suicidal ideation with intent or plan in the 6 months prior to screening
- Weight > 86.95 kg (191.2 lbs)
- Subthreshold pharmacoBOLD response during screening ketamine infusion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35233
University of California, Los Angeles
Los Angeles, California, 90095
New York University
New York, New York, 10016
Columbia University
New York, New York, 10032
About this study
Official title: Biomarker Assessment of Pomaglumetad on Glutamate Targets: Proof of Clinical Mechanism of Action (POCM)
The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).
Read the detailed description
This study evaluates the effects of POMA at selected doses on ketamine-stimulated glutamate increase in the prefrontal cortex hypothesized to simulate the synaptic dysregulation that occurs endogenously in the pathogenesis of schizophrenia. The purpose of this is: 1) to determine whether the low dose (40 mg BID) utilized in recent (failed) clinical trials is sufficient to engage the primary target and 2) whether a higher (160 mg BID) dose, representing the maximum tolerated dose of POMA, engages the target to a greater degree. This study will further validate pharmacoBOLD as biomarker of mGluR2/3 target engagement, permitting its future use in other glutamatergic drug development.
- Conditions
- Healthy Controls
- Being tested
- POMA, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POMADrug
Also called Pomaglumetad
Pomaglumetad ("POMA") is a mGluR 2/3 partial agonist
placeboDrug
Also called placebo comparator
matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| POMA 40 mg BID | Experimental | 40 mg BID for 10 days Receives: Drug: POMA |
| POMA 160 mg BID | Experimental | 160 mg BID for 10 days Receives: Drug: POMA |
| Placebo | Placebo comparator | Placebo BID for 10 days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PharmacoBOLD change
pharmacoBOLD change, as summarized by the Amplitude measure
Measured: Day 1 to Day 10
Secondary outcomes (2)
Brief Psychiatric Rating Scale (BPRS)
Clinical rating scale assessing common psychiatric symptoms
Measured: Day 1 to Day 10
Clinician Administered Dissociative States Scale (CADSS)
Rates dissociative symptoms
Measured: Day 1 to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion28 Apr 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Marlene Carlson, New York State Psychiatric Institute
- Investigators
- Jeffrey A Lieberman, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919774
- Sponsor's protocol ID
- 7285
- Other IDs
- 271201200007I-4-27100003-2
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2016
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Submit to NDCT
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Assessment of Pomaglumetad on Glutamate Targets: Proof of Clinical Mechanism of Action (POCM)
- ClinicalTrials.gov ID
- NCT02919774
- Acronym / sponsor ID
- 7285
- Conditions
- Healthy Controls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2016 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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.
The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).
Detailed description
This study evaluates the effects of POMA at selected doses on ketamine-stimulated glutamate increase in the prefrontal cortex hypothesized to simulate the synaptic dysregulation that occurs endogenously in the pathogenesis of schizophrenia. The purpose of this is: 1) to determine whether the low dose (40 mg BID) utilized in recent (failed) clinical trials is sufficient to engage the primary target and 2) whether a higher (160 mg BID) dose, representing the maximum tolerated dose of POMA, engages the target to a greater degree. This study will further validate pharmacoBOLD as biomarker of mGluR2/3 target engagement, permitting its future use in other glutamatergic drug development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| POMA 40 mg BID | Experimental | Drug: POMA40 mg BID for 10 days |
| POMA 160 mg BID | Experimental | Drug: POMA160 mg BID for 10 days |
| Placebo | Placebo comparator | Drug: placeboPlacebo BID for 10 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically healthy
- Capable of understanding the study procedures and able to provide informed consent
- Men and women must agree to use a reliable method of birth control during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible
Key exclusion criteria (15 listed)
- Current or past Axis I psychiatric history
- Positive urine toxicology
- History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated in prior research ketamine studies will be eligible. Subjects can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore subjects entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
- History of first-degree relative with schizophrenia
- History of violence
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 |
|---|---|---|
| POMAAlso: PomaglumetadPomaglumetad ("POMA") is a mGluR 2/3 partial agonist | Drug | POMA 160 mg BID, POMA 40 mg BID |
| placeboAlso: placebo comparatormatching placebo tablets | Drug | Placebo |
Primary outcome
PharmacoBOLD change
Time frame: Day 1 to Day 10
pharmacoBOLD change, as summarized by the Amplitude measure
2 secondary outcomes
Brief Psychiatric Rating Scale (BPRS)
Time frame: Day 1 to Day 10
Clinician Administered Dissociative States Scale (CADSS)
Time frame: Day 1 to Day 10
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 12 Sep 2018.
- Individual participant dataSharing planned: Yes. Submit to NDCT
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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.
Jeffrey A Lieberman, MD principal investigator
New York State Psychiatric Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing POMA in people with Healthy Controls, run by New York State Psychiatric Institute at 4 sites 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 15 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
PharmacoBOLD change (time frame: Day 1 to Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2018.