SchizophreniaPhase 1NCT02824666
Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242
A Phase 1 study testing ATI-9242 and [18F]Fallypride Imaging in people with Schizophrenia, run by Braeburn Pharmaceuticals at 1 site in United States.
Trial summary
This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts of subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- ATI-9242 and [18F]Fallypride Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2016to 8 Nov 2016
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are males > 18 years of age and < 50 years of age.
- BMI <30
- Are in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Are able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
- Provide informed consent for study procedures.
- Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects and for 90 days after the end of the study.
Show all 9Show fewer
- Subjects must not donate sperm for the study duration and for 90 days after the end of the study.
- Willing and able to cooperate with study procedures
- A brain MRI within the past 120 days with no evidence of active or focal neurological disease that may interfere with the [18F]Fallypride PET data.
Who cannot join
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to Baseline imaging, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to Baseline imaging. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication/significant non-drug therapy.
- Exposure to any investigational drug within the 4 weeks prior to screening visit.
- Subjects with a history of exposure to any radiation >15 mSv/year (e.g., occupational or radiation therapy) over the past year.
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study.
- Have clinically significant findings on laboratory evaluations in the opinion of the investigator.
Show all 13Show fewer
- Have clinically significant findings on ECG evaluation.
- A positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or HIV test result.
- History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- History of tobacco product use within 3 months prior to screening, to be verified by urine cotinine screening.
- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI.
- Claustrophobia that would interfere with completion of MRI and/or SPECT procedures.
- Inability to lie supine for 90 minutes at a time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Clinical Research Center, IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Phase 1, Open-Label Positron Emission Tomography (PET) Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242 in Adult Male Healthy Subjects
This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts of subjects.
Read the detailed description
This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using [18F]Fallypride PET in up to three cohorts of subjects. The first dose evaluated will be 0.5 mg/kg administered as an IV bolus injection. The second dose that will be evaluated will be 1.0 mg/kg as an IV bolus injection. The safety and occupancy after each dose level will be evaluated prior to moving to the next dose. On two separate days, subjects will undergo [18F]Fallypride PET imaging sessions. The plasma concentration of ATI-9242 will be obtained prior to and during the course of the imaging session to allow determination of the relationship between plasma concentration of ATI-9242 with in vivo D2 occupancy.
- Conditions
- Schizophrenia
- Being tested
- ATI-9242, [18F]Fallypride Imaging
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATI-9242Drug
Formulated ATI-9242 will be administered as an IV bolus injection (2mg/mL of ATI-9242 in 40% solution of propylene glycol).
Two doses will be tested: single IV bolus injection of 0.5mg/kg and single IV bolus injection 1.0 mg/kg. In the event that a third cohort is needed the IV bolus injection would be 2.0 mg/kg
[18F]Fallypride ImagingRadiation
Subjects will be injected with approximately 250 MBq or 6.75 mCi of [18F]Fallypride [5-6 mCi being the typical range of injected dose].
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg/kg | Experimental | • Cohort 1: ATI-9242 - Single IV bolus dose of 0.5 mg/kg Receives: Drug: ATI-9242; Radiation: [18F]Fallypride Imaging |
| ATI-9242 1.0 mg/kg | Experimental | • Cohort 2: ATI-9242 - Single IV bolus dose of 1.0 mg/kg Receives: Drug: ATI-9242; Radiation: [18F]Fallypride Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target receptor occupancy after single intravenous(IV) of ATI-9242 in 6 healthy adults using the D2 receptor ligand [18F]Fallypride and PET imaging.
Change from baseline in PET imaging at baseline of ATI-9242 and post-dose
Measured: approximately 5 weeks
Secondary outcomes (1)
Explore the relationship between ATI-9242 dose, plasma concentrations of ATI-9242 and target receptor occupancy in 6 subjects.
The relationship between plasma drug concentration/PK parameters of ATI-9242 and D2 occupancy will be explored.
Measured: approximately 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start20 Jun 2016
- Primary completion6 Sep 2016
- Study completion8 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braeburn Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824666
- Sponsor's protocol ID
- BB-ATI9242-001
- Status last verified
- Jul 2017
- First submitted
- 8 Jun 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label Positron Emission Tomography (PET) Study to Evaluate D2 Receptor Occupancy Following Single Intravenous Administration of ATI-9242 in Adult Male Healthy Subjects
- ClinicalTrials.gov ID
- NCT02824666
- Acronym / sponsor ID
- BB-ATI9242-001
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Braeburn PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 6 Sep 2016 (actual)
- Study completion
- 8 Nov 2016 (actual)
- First posted
- 7 Jul 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.
This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using [18F] Fallypride PET in up to three cohorts of subjects.
Detailed description
This study involves evaluating the occupancy of ATI-9242 at steady state at three different dose levels on D2 receptors in the brain using [18F]Fallypride PET in up to three cohorts of subjects. The first dose evaluated will be 0.5 mg/kg administered as an IV bolus injection. The second dose that will be evaluated will be 1.0 mg/kg as an IV bolus injection. The safety and occupancy after each dose level will be evaluated prior to moving to the next dose. On two separate days, subjects will undergo [18F]Fallypride PET imaging sessions. The plasma concentration of ATI-9242 will be obtained prior to and during the course of the imaging session to allow determination of the relationship between plasma concentration of ATI-9242 with in vivo D2 occupancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg/kg | Experimental | Drug: ATI-9242, Radiation: [18F]Fallypride Imaging• Cohort 1: ATI-9242 - Single IV bolus dose of 0.5 mg/kg |
| ATI-9242 1.0 mg/kg | Experimental | Drug: ATI-9242, Radiation: [18F]Fallypride Imaging• Cohort 2: ATI-9242 - Single IV bolus dose of 1.0 mg/kg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Are males > 18 years of age and < 50 years of age.
- BMI <30
- Are in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Are able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
- Provide informed consent for study procedures.
Key exclusion criteria (13 listed)
- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to Baseline imaging, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to Baseline imaging. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication/significant non-drug therapy.
- Exposure to any investigational drug within the 4 weeks prior to screening visit.
- Subjects with a history of exposure to any radiation >15 mSv/year (e.g., occupational or radiation therapy) over the past year.
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
- Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study.
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 |
|---|---|---|
| ATI-9242Formulated ATI-9242 will be administered as an IV bolus injection (2mg/mL of ATI-9242 in 40% solution of propylene glycol). Two doses will be tested: single IV bolus injection of 0.5mg/kg and single IV bolus injection 1.0 mg/kg. In the event that a third cohort is needed the IV bolus injection would be 2.0 mg/kg | Drug | 0.5 mg/kg, ATI-9242 1.0 mg/kg |
| [18F]Fallypride ImagingSubjects will be injected with approximately 250 MBq or 6.75 mCi of [18F]Fallypride [5-6 mCi being the typical range of injected dose]. | Radiation | 0.5 mg/kg, ATI-9242 1.0 mg/kg |
Primary outcome
Target receptor occupancy after single intravenous(IV) of ATI-9242 in 6 healthy adults using the D2 receptor ligand [18F]Fallypride and PET imaging.
Time frame: approximately 5 weeks
Change from baseline in PET imaging at baseline of ATI-9242 and post-dose
1 secondary outcome
Explore the relationship between ATI-9242 dose, plasma concentrations of ATI-9242 and target receptor occupancy in 6 subjects.
Time frame: approximately 5 weeks
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 17 Jul 2017.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
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 ATI-9242 and [18F]Fallypride Imaging in people with Schizophrenia, run by Braeburn Pharmaceuticals 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 9 inclusion and 13 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 17 Jul 2017. 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. 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?
Target receptor occupancy after single intravenous(IV) of ATI-9242 in 6 healthy adults using the D2 receptor ligand [18F]Fallypride and PET imaging. (time frame: approximately 5 weeks). 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 17 Jul 2017.