SchizophreniaPhase 1NCT04588129
Receptor Occupancy of LB-102 Using Positron Emission Tomography (PET) in Healthy Volunteers
A Phase 1 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LB-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 15 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- Heart rate < 40 bpm and > 100 bpm (based on the ECG reading)
- QTcF interval > 450 msec for males and females
- PR interval ≥ 200 msec
- Intraventricular conduction delay with QRS duration > 120 msec
- Evidence of second- or third-degree atrioventricular block (AVB)
- Electrocardiographic evidence of complete left bundle branch block (LBBB), complete right bundle branch block (RBBB), or incomplete LBBB
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- LB-102
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-102Drug
(N-Methyl amisulpride)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: LB-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Receptor Occupancy as Measured by Positron Emission Tomography
PET scan of D2/D3 receptor occupancy using raclopride as a tracer
Measured: 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
Measured: 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
Measured: 23.5 hours post LB-102 dose
Secondary outcomes (1)
Safety and Tolerability as Measured by Reported Adverse Events
Measurement of clinical events as determined by medical staff reporting
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start5 Jan 2021
- Primary completion17 Sep 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- LB Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Dean Wong, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588129
- Sponsor's protocol ID
- LB-102-002
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Positron Emission Tomography (PET) Study to Evaluate Dopamine Receptor Occupancy of LB-102 Administered Orally to Healthy Subjects
- ClinicalTrials.gov ID
- NCT04588129
- Acronym / sponsor ID
- LB-102-002
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- LB Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Washington University School of Medicine
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LB-102 50 mg, single dose Cohort 1 | Experimental | Drug: LB-102LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 100 mg, single dose Cohort 2 | Experimental | Drug: LB-102LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 75 mg, single dose Cohort 3 | Experimental | Drug: LB-102LB-102 (N-Methyl amisulpride) formulated capsule will be administered orally once daily for one day in 4 subjects. |
| LB-102 100 & 50 mg, multiple dose Cohort 4 | Experimental | Drug: LB-102LB-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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB-102(N-Methyl amisulpride) | Drug | 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 |
Primary outcome
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
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
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
1 secondary outcome
Safety and Tolerability as Measured by Reported Adverse Events
Time frame: Up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Corporate WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Wong, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Receptor Occupancy as Measured by Positron Emission Tomography (time frame: 2.5 hours post LB-102 dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.