This is an open label study in 4 cohort of 4 healthy volunteers each designed to evaluate the dopamine receptor occupancy of LB-102 at various doses and timepoints.
This is a Phase 1, open label study designed to evaluate the dopamine receptor occupancy in healthy subjects. There will be 4 cohorts consisting of 4 subjects each. Eligible subjects will receive 1 or 2 doses of LB-102 on Day 1: subjects in the final cohort will be dosed for 5 days BID (ie twice/day) on an inpatient basis. This will be an open label study. Blood samples for pharmacokinetic (PK) and safety assessments will be collected at screening, immediately pre-dose, and during/before/after PET scan. Subjects enrolled in the inpatient cohort will be monitored daily. Follow-up after discharge will consist of a phone call the evening of discharge and the next day to check on subjects. This will be an adaptive study and doses in cohorts 2-4 will be determined after PET data from Cohort 1 are obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
(N-Methyl amisulpride)
Washington University School of Medicine
St Louis, Missouri, United States
Brain Receptor Occupancy as Measured by Positron Emission Tomography
PET scan of D2/D3 receptor occupancy using raclopride as a tracer
Time frame: 2.5 hours post LB-102 dose
Brain Receptor Occupancy as Measured by Positron Emission Tomography
PET scan of D2/D3 receptor occupancy using raclopride as a tracer
Time frame: 7.5 hours post LB-102 dose
Brain Receptor Occupancy as Measured by Positron Emission Tomography
PET scan of D2/D3 receptor occupancy using raclopride as a tracer
Time frame: 23.5 hours post LB-102 dose
Safety and Tolerability as Measured by Reported Adverse Events
Measurement of clinical events as determined by medical staff reporting
Time frame: Up to 14 days
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