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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) is >= 18.0 to <= 35.0 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
ABBV-932
Participants will receive ABBV-932.
干预措施: ABBV-932 (Drug)
结局指标
主要结局
Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET)
时间窗: 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.
Number of Participants with Adverse Events (AEs)
时间窗: 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.
次要结局
未报告次要终点