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

NCT06300580 | Completed Phase 1

• 1 other identifier: M23-991
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; ABBV-932

Outcome Measures

Primary Outcomes (2)

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

  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.

  Up to approximately 14 days

• Number of Participants with Adverse Events (AEs)

  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.

  Up to approximately 74 days

Study Arms (1)

ABBV-932

EXPERIMENTAL

Participants will receive ABBV-932.

Drug: ABBV-932

Interventions

ABBV-932 DRUG

Oral Capsule

ABBV-932

Eligibility Criteria

• Age: 23 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Parexel Early Phase Clinical Unit /ID# 264286

Harrow, HA1 3UJ, United Kingdom

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 8, 2024
• Study Start: August 21, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)