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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300580
• Other study ID #: M23-991
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 3, 2024
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABBV-932
Oral Capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

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