Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers

Last updated: June 3, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

ABBV-932

Clinical Study ID

NCT06300580
M23-991
  • Ages 23-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 atScreening.

  • Supine systolic blood pressure (SBP) <= 160 mm Hg and >= 90 mm Hg and supinediastolic blood pressure (DBP) <= 90 mm Hg and obtained after a 5-minute rest atScreening.

Exclusion

Exclusion Criteria:

  • Orthostatic (SBP decrease of >= 30 mmHg, DBP decrease of >= 20 mmHg, or pulseincrease of >= 30 bpm) as determined after standing for 5 minutes.

  • Current or history of suicidal ideation as indicated by answering "Yes" answer toSuicidal 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 BehaviorQuestions #1-5 in the past year. Non-suicidal self-injurious behavior is notexclusionary.

  • History of suicide attempt(s) within 1 year prior to study drug administration asevidenced by answering "Yes" to any Suicidal Behavior Questions (a "Yes" toNon-Suicidal Self-Injurious Behavior is not exclusionary).

  • Contraindications to MRIs (metal implants, paramagnetic objects contained within thebody, claustrophobia, etc.)

  • Clinically significant findings as determined from screening brain MRI.

  • History of previous radiation exposure for research purposes such that participationin this study will result in cumulative ionizing radiation exposure >10 mSv in thepast 12 months, in additional to normal background exposure.

Study Design

Total Participants: 11
Treatment Group(s): 1
Primary Treatment: ABBV-932
Phase: 1
Study Start date:
August 21, 2024
Estimated Completion Date:
May 26, 2025

Connect with a study center

  • Parexel Early Phase Clinical Unit /ID# 264286

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

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