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Completed

NCT Number: NCT06300580

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

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.

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Key information

Conditions

Age range

23 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Clinical Unit /ID# 264286

Harrow, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-932

Drug

Oral Capsule

Primary outcomes

  1. Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET)

    Time frame: 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.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Acronym: Ph1PET UK Stdy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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