Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, ABBV-932
Brief 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.
Interventions
DRUGABBV-932
Oral Capsule
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET) | Up to approximately 14 days | Dopamine D2 and D3 Receptor Occupancy in the brain up to Day 14 after multiple doses of ABBV-932 will be measured by PET. The occupancies will be determined by evaluating the difference in the binding potential (BPND) measured between baseline and post-dose scans in various brain regions. |
| Number of Participants with Adverse Events (AEs) | Up to approximately 74 days | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Countries
United Kingdom
Outcome results
None listed