A Positron Emission Tomography (PET) Study to Evaluate Dopamine D2 and D3 Receptor Occupancy by S… (NCT07626034) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Positron Emission Tomography (PET) Study to Evaluate Dopamine D2 and D3 Receptor Occupancy by SIPI6398
9 participantsStarted 2026-08
Plain-language summary
This is an open label study in 2 cohorts of healthy volunteers and 1 cohort of patients with Schizophrenia, designed to evaluate the Dopamine D2 and D3 Receptor Occupancy by SIPI6398 at various doses and timepoints.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant is aged 18-55 years, inclusive.
. BMI between 19.0 and 32.0 kg/m2, inclusive.
. Participant is medically healthy as determined by clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the Screening visit and before administration of the initial dose of study drug.
. Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements.
. Participant is capable of providing informed consent.
. Participant is aged 18-55 years, inclusive.
. BMI between 19.0 and 35.0 kg/m2, inclusive.
. Currently meet a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Diagnosis and differential will be confirmed by using the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies version 7.0.2 at Screening Visit.
Exclusion criteria
. Women of childbearing potential (WOCBP), or fertile men whose sexual partners are WOCBP, who are unwilling or unable to use at least 1 highly effective method of contraception during the study and for 90 days following the last dose of trial medication. A female participant is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 months or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brain dopamine D2 and D3 receptor occupancy following oral doses as measured by PET.
Timeframe: Baseline and post-dose, up to 9 days for healthy volunteers and up to 8 days for schizophrenia patients
. Females who are pregnant, lactating, or less than 90 days postpartum prior to the Screening Visit.
. History or presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine, or psychiatric disease, considered by the investigator.
. Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS as confirmed by the following: Answers "Yes" to any of the 5 items (C-SSRS - ideation) within the 3 months before Screening or between the Screening and Baseline Visits, or answers "Yes" to any of the 5 items (C-SSRS behavior) within the 12 months before Screening or between the Screening and Baseline Visits, or has a history of nonsuicidal, self-injurious behavior in the past 12 months.
. History of current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen (HBsAg) and/or anti- hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibodies or treponema pallidum antibody.
. Participants who had any major surgery, any blood transfusion, donation of blood or plasma within 30 days prior to Screening Visit.
. Participants with a history of allergy to more than one class of medications or known to be allergic to any components of the study drug or the radioligand.
. Clinically significant abnormal findings on the physical examination, vital signs, 12-lead ECG, or clinical laboratory results.