SchizophreniaPhase 1NCT04187560
Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults
A Phase 1 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 1 site in United States.
Trial summary
A Single Ascending Dose (SAD; Part A) and Multiple Ascending Dose (MAD; Part B) Phase 1 Study of LB-102 N-Methyl amisulpride) in healthy volunteers. The primary objective is to evaluate the safety and the tolerability of a single oral dose (SAD) and multiple oral doses (MAD) of LB-102 as compared to placebo. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 9 Nov 2020
- 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
- Subjects may be included in the study only if they meet all of the following criteria:
- Competent to provide informed consent.
- Voluntarily provide informed consent.
- Healthy adult male and female subjects between 18 to 55 years of age inclusive at the screening visit.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 at screening visit.
- 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.
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- Have normal clinical laboratory test results and ECG, which are not considered to be clinically significant by the investigator.
- Female subjects of child-bearing potential must agree to use two methods of an acceptable method of birth control (e.g., condom and spermicide, intrauterine device (IUD), oral contraception which has been stable for 30 days) and at least 90 days after stopping the investigational product. Female subjects using oral contraception whose partner consistently uses condoms or who is vasectomized is also acceptable.
- Male subjects must be surgically sterile or practicing at least one method of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug:
- Male subjects must agree to abstain from sperm donation through 90 days after administration of the last dose of investigational drug.
Who cannot join
- Subjects will be excluded from the study for any of the following reasons:
- Are pregnant or lactating.
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological 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, vital signs, or ECG.
- History or presence of psychiatric or neurological disease or condition.
- History of seizures.
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- Subject with any history or current evidence of suicidal behavior.
- Unwilling to complete any planned study assessments, including the Columbia-Suicide Severity Rating Scale (CSSRS).
- Recent history of alcohol or drug abuse (within the last two years).
- Any use of tobacco or tobacco-containing products (cigarettes, pipes, etc.) within one month prior to screening.
- 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.
- Use of any prescription or over the counter medication, herbal medications, vitamins, or supplements within 14 days prior to study drug administration.
- Have a positive test for human immunodeficiency virus (HIV) antibodies 1 and 2, Hepatitis B surface antigen or Hepatitis C antibody.
- Any subject who is known to be allergic to the study drug or any components of the study drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology LLC
Cincinnati, Ohio, 45227
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LB-102 Administered Orally to Healthy Subjects
A Single Ascending Dose (SAD; Part A) and Multiple Ascending Dose (MAD; Part B) Phase 1 Study of LB-102 N-Methyl amisulpride) in healthy volunteers. The primary objective is to evaluate the safety and the tolerability of a single oral dose (SAD) and multiple oral doses (MAD) of LB-102 as compared to placebo. The secondary objectives are to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of LB-102.
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of LB-102 in healthy subjects. The study will consist of two parts: Part A - Single Ascending Dose and Part B - Multiple Ascending Doses. There will be 5 cohorts in Part A and 3 Cohorts in Part B of this study. Each cohort consists of 8 subjects, with 6 subjects assigned to LB-102 and 2 subjects assigned to placebo.
In Parts A and B, eligible subjects will be randomized on Day 1 (pre-dose) to placebo (n=2) or LB-102 (n=6). Eligible subjects will receive 1 dose on Day 1 (Part A) or 13 doses on Days 1-7 (Part B) of placebo or LB-102.
- 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
Also called Active Drug
(N-Methyl amisulpride)
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1 | Active comparator | LB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day Receives: Drug: LB-102 |
| Part A Cohort 2 | Active comparator | LB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day Receives: Drug: LB-102 |
| Part A Cohort 3 | Active comparator | LB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day Receives: Drug: LB-102 |
| Part A Cohort 4 | Active comparator | LB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day Receives: Drug: LB-102 |
| Part A Cohort 5 | Active comparator | LB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day Receives: Drug: LB-102 |
| Part B Cohort 6 | Active comparator | LB-102 50 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) Receives: Drug: LB-102 |
| Part B Cohort 7 | Active comparator | LB-102 100 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) Receives: Drug: LB-102 |
| Part B Cohort 8 | Active comparator | LB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) Receives: Drug: LB-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who experience at least one treatment-emergent adverse event (TEAE)
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
Measured: Day 8 (Part A) or Day 15 (Part B)
Secondary outcomes (4)
Tmax: Time to Reach the Maximum Plasma Concentration
Time to reach the maximum observed plasma concentration for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 7).
Measured: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
Cmax: Maximum Observed Plasma Concentration
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax will be measured for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 7).
Measured: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration
AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the Last Quantifiable Concentration and will be measured for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 7)
Measured: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose
AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose for LB-102 and LB-102 metabolite amisulpride after a single dose (Day 1) and multiple dosing (Day 14).
Measured: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start22 Jan 2020
- Primary completion1 Jul 2020
- Study completion9 Nov 2020
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- LB Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lukasz Biernat, MD, Principal investigator, Medpace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187560
- Sponsor's protocol ID
- LB-102-001
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2019
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LB-102 Administered Orally to Healthy Subjects
- ClinicalTrials.gov ID
- NCT04187560
- Acronym / sponsor ID
- LB-102-001
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- LB Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 5 Dec 2019 (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.
A Single Ascending Dose (SAD; Part A) and Multiple Ascending Dose (MAD; Part B) Phase 1 Study of LB-102 N-Methyl amisulpride) in healthy volunteers. The primary objective is to evaluate the safety and the tolerability of a single oral dose (SAD) and multiple oral doses (MAD) of LB-102 as compared to placebo. The secondary objectives are to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of LB-102.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of LB-102 in healthy subjects. The study will consist of two parts: Part A - Single Ascending Dose and Part B - Multiple Ascending Doses. There will be 5 cohorts in Part A and 3 Cohorts in Part B of this study. Each cohort consists of 8 subjects, with 6 subjects assigned to LB-102 and 2 subjects assigned to placebo.
In Parts A and B, eligible subjects will be randomized on Day 1 (pre-dose) to placebo (n=2) or LB-102 (n=6). Eligible subjects will receive 1 dose on Day 1 (Part A) or 13 doses on Days 1-7 (Part B) of placebo or LB-102.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1 | Active comparator | Drug: LB-102LB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 2 | Active comparator | Drug: LB-102LB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 3 | Active comparator | Drug: LB-102LB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 4 | Active comparator | Drug: LB-102LB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day |
| Part A Cohort 5 | Active comparator | Drug: LB-102LB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day |
| Part B Cohort 6 | Active comparator | Drug: LB-102LB-102 50 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Part B Cohort 7 | Active comparator | Drug: LB-102LB-102 100 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
| Part B Cohort 8 | Active comparator | Drug: LB-102LB-102 75 mg (n=6) or Matching Placebo (n=2) BID x 7 days (QD on Day 7) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Competent to provide informed consent.
- Voluntarily provide informed consent.
- Healthy adult male and female subjects between 18 to 55 years of age inclusive at the screening visit.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m2 at screening visit.
- 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.
Key exclusion criteria (15 listed)
- Are pregnant or lactating.
- Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological 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, vital signs, or ECG.
- History or presence of psychiatric or neurological disease or condition.
- History of seizures.
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-102Also: Active Drug(N-Methyl amisulpride) | Drug | Part A Cohort 1, Part A Cohort 2, Part A Cohort 3, Part A Cohort 4, Part A Cohort 5, Part B Cohort 6, Part B Cohort 7, Part B Cohort 8 |
Primary outcome
Percentage of participants who experience at least one treatment-emergent adverse event (TEAE)
Time frame: Day 8 (Part A) or Day 15 (Part B)
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
4 secondary outcomes
Tmax: Time to Reach the Maximum Plasma Concentration
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
Cmax: Maximum Observed Plasma Concentration
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose
Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)
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 10 Dec 2020.
- Corporate WebsiteLink provided by the sponsor.
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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.
Lukasz Biernat, MD principal investigator
Medpace, Inc.
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 10 inclusion and 15 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 10 Dec 2020. 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?
Percentage of participants who experience at least one treatment-emergent adverse event (TEAE) (time frame: Day 8 (Part A) or Day 15 (Part B)). 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 10 Dec 2020.