Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588129
Status:
COMPLETED
Last Update Posted:
2022-05-04
First Post:
2020-10-06
Brief Title:
Receptor Occupancy of LB-102 Using Positron Emission Tomography PET in Healthy Volunteers
Sponsor:
LB Pharmaceuticals Inc
Organization:
LB Pharmaceuticals Inc
Study Overview
Official Title:
An Open Label Positron Emission Tomography PET Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 twiceday 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 duringbeforeafter 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None