Clinical trial NCT06300580: Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers
Official title: An Open-Label Positron Emission Tomography (PET) Study to Evaluate the Dopamine D2 and D3 Receptor Occupancy in the Brain After Multiple Doses of ABBV-932
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
ABBV-932
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 11
Sex: ALL
Minimum age (years): 23
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET)
timeFrame: Up to approximately 14 days
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 74 days
Secondary outcomes:
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Parexel Early Phase Clinical Unit /ID# 264286
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: