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

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ClinicalTrials.gov Identifier: NCT04588129
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
LB Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: LB-102 Phase 1

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects
Actual Study Start Date : January 5, 2021
Actual Primary Completion Date : September 17, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LB-102 50 mg, single dose Cohort 1
LB-102 formulated capsule will be administered orally once daily for one day in up to 4 subjects.
Drug: LB-102
(N-Methyl amisulpride)

Experimental: LB-102 xx mg, single dose Cohort 2
LB-102 formulated capsule will be administered orally once daily for one day in up to 4 subjects.
Drug: LB-102
(N-Methyl amisulpride)

Experimental: LB-102 xx mg, single dose Cohort 3
LB-102 formulated capsule will be administered orally once daily for one day in up to 4 subjects.
Drug: LB-102
(N-Methyl amisulpride)

Experimental: LB-102 xx mg, multiple dose Cohort 4
LB-102 formulated capsule will be administered orally twice daily for one day in up to 4 subjects.
Drug: LB-102
(N-Methyl amisulpride)




Primary Outcome Measures :
  1. Brain Receptor Occupancy as Measured by Positron Emission Tomography [ Time Frame: 2.5 hours post LB-102 dose ]
    PET scan of D2/D3 receptor occupancy using raclopride as a tracer

  2. Brain Receptor Occupancy as Measured by Positron Emission Tomography [ Time Frame: 7.5 hours post LB-102 dose ]
    PET scan of D2/D3 receptor occupancy using raclopride as a tracer

  3. Brain Receptor Occupancy as Measured by Positron Emission Tomography [ Time Frame: 23.5 hours post LB-102 dose ]
    PET scan of D2/D3 receptor occupancy using raclopride as a tracer


Secondary Outcome Measures :
  1. Safety and Tolerability as Measured by Reported Adverse Events [ Time Frame: Up to 14 days ]
    Measurement of clinical events as determined by medical staff reporting



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  1. Are pregnant or lactating.
  2. 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.
  3. Clinically significant abnormal findings on physical examination or vital signs as determined by Investigator.
  4. 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.
  5. History or presence of psychiatric or neurological disease or condition, as determined by the Investigator.
  6. History of seizures.
  7. Subject with any history or current evidence of suicidal behavior.
  8. Unwilling to complete any planned study assessments.
  9. Have a history of blood donation in excess of 500 mL of blood within 30 days prior to Screening.
  10. Have received treatment with an investigational drug or device within 30 days prior to Screening.
  11. Have a positive test for Human Immunodeficiency Virus (HIV) antibodies 1 and 2, Hepatitis B Surface Antigen (HBsAg) or Hepatitis C Virus (HCV) antibody.
  12. Any subject who is known to be allergic to the study drug or any components of the study drug.
  13. The subject has a fasting blood glucose ≥ 126 mg/dL or hemoglobin A1c (HbA1c) ≥ 6.5% at Screening.
  14. The subject has a history of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
  15. Clinically significant abnormal finding on ECG (electrocardiogram) and/or evidence of any of the following cardiac conduction abnormalities at Screening:

    1. Heart rate < 40 bpm and > 100 bpm (based on the ECG reading)
    2. QTcF interval > 450 msec for males and females
    3. PR interval ≥ 200 msec
    4. Intraventricular conduction delay with QRS duration > 120 msec
    5. Evidence of second- or third-degree atrioventricular block (AVB)
    6. Electrocardiographic evidence of complete left bundle branch block (LBBB), complete right bundle branch block (RBBB), or incomplete LBBB

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588129


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
LB Pharmaceuticals Inc.
Washington University School of Medicine
Investigators
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Principal Investigator: Dean Wong, PhD Washington University School of Medicine
Additional Information:
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Responsible Party: LB Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04588129    
Other Study ID Numbers: LB-102-002
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders