Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adu… (NCT06300580) | Clinical Trial Compass
CompletedPhase 1
Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers
United Kingdom11 participantsStarted 2024-08-21
Plain-language summary
The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer \[11C\]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects.
ABBV-932 is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom.
Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days.
Participants will be confined for approximately 15 days. Participants will receive 3 \[11C\]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed.
Who can participate
Age range
23 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:
* Body Mass Index (BMI) is \>= 18.0 to \<= 35.0 kg/m2.
* Supine pulse rate \>= 50 bpm and \<= 100 bpm obtained after a 5-minute rest at Screening.
* Supine systolic blood pressure (SBP) \<= 160 mm Hg and \>= 90 mm Hg and supine diastolic blood pressure (DBP) \<= 90 mm Hg and obtained after a 5-minute rest at Screening.
Exclusion Criteria:
* Orthostatic (SBP decrease of \>= 30 mmHg, DBP decrease of \>= 20 mmHg, or pulse increase of \>= 30 bpm) as determined after standing for 5 minutes.
* Current or history of suicidal ideation as indicated by answering "Yes" answer to Suicidal Ideation Questions #4 or #5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening in the past 3 months or any "Yes" answer to Suicidal Behavior Questions #1-5 in the past year. Non-suicidal self-injurious behavior is not exclusionary.
* History of suicide attempt(s) within 1 year prior to study drug administration as evidenced by answering "Yes" to any Suicidal Behavior Questions (a "Yes" to Non-Suicidal Self-Injurious Behavior is not exclusionary).
* Contraindications to MRIs (metal implants, paramagnetic objects contained within the body, claustrophobia, etc.)
* Clinically significant findings as determined from screening brain MRI.
* History of previous radiation exposure for research purposes such that participation in this study will result in cumulative ionizing radiation exposure \>10 mSv in the past 12 months, in additional to normal background exposure.
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
Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET)