Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers

NCT04588129 | Completed Phase 1 FDA Drug

• 1 other identifier: LB-102-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Brain Receptor Occupancy as Measured by Positron Emission Tomography

  PET scan of D2/D3 receptor occupancy using raclopride as a tracer

  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

  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

  23.5 hours post LB-102 dose

Secondary Outcomes (1)

• Safety and Tolerability as Measured by Reported Adverse Events

  Up to 14 days

Study Arms (4)

LB-102 50 mg, single dose Cohort 1

EXPERIMENTAL

LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects.

Drug: LB-102

LB-102 100 mg, single dose Cohort 2

EXPERIMENTAL

LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects.

Drug: LB-102

LB-102 75 mg, single dose Cohort 3

EXPERIMENTAL

LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects.

Drug: LB-102

LB-102 100 & 50 mg, multiple dose Cohort 4

EXPERIMENTAL

LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for four days in 4 subjects: 2 subjects @ 100 mg and 2 subjects @ 50 mg.

Drug: LB-102

Interventions

LB-102 DRUG

(N-Methyl amisulpride)

LB-102 100 & 50 mg, multiple dose Cohort 4; LB-102 100 mg, single dose Cohort 2; LB-102 50 mg, single dose Cohort 1; LB-102 75 mg, single dose Cohort 3

Eligibility Criteria

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

You may qualify if:

• Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 at screening visit. Competent to provide informed consent.
• Subjects must be in good general health as determined by medical history and physical examination with no clinically significant medical findings and no history of significant medical disease (e.g., cardiovascular, pulmonary, renal, etc.) or acute condition with the past 30 days, as determined by the study investigators.
• Have normal clinical laboratory test results and ECG, which are not considered to be clinically significant by the Investigator.

You may not qualify if:

• Are pregnant or lactating.
• Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological or psychological/psychiatric disorders which, in the opinion of the Investigator, increases the risk of the study drug or may confound the interpretation of study measures.
• Clinically significant abnormal findings on physical examination or vital signs as determined by Investigator.
• Individuals with pacemakers, aneurysm clips, shrapnel, or other restricted implanted metallic devices will be excluded from study. All subjects complete the standard MRI screening questionnaire prior to MRI.
• History or presence of psychiatric or neurological disease or condition, as determined by the Investigator.
• History of seizures.
• Subject with any history or current evidence of suicidal behavior.
• Unwilling to complete any planned study assessments.
• Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Screening.
• Have received treatment with an investigational drug or device within 30 days prior to Screening.
• Have a positive test for Human Immunodeficiency Virus (HIV) antibodies 1 and 2, Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV) antibody.
• Any subject who is known to be allergic to the study drug or any components of the study drug.
• The subject has a fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c (HbA1c) ≥ 6.5% at Screening.
• The subject has a history of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
• Clinically significant abnormal finding on ECG (electrocardiogram) and/or evidence of any of the following cardiac conduction abnormalities at Screening:

Sponsors & Collaborators

• LB Pharmaceuticals Inc.: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Corporate Website

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Dean Wong, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 19, 2020
• Study Start: January 5, 2021
• Primary Completion: September 17, 2021
• Study Completion: November 15, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)