Safety and Tolerability of Single and Multiple Doses of LB-102 in Healthy Adults

NCT04187560 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: LB-102-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. The secondary objectives are to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of LB-102.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 8 (Part A) or Day 15 (Part B)

Secondary Outcomes (4)

• Tmax: Time to Reach the Maximum Plasma Concentration

  Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)

• Cmax: Maximum Observed Plasma Concentration

  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

  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

  Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)

Study Arms (8)

Part A Cohort 1

ACTIVE COMPARATOR

LB-102 50 mg (n=6) or Matching Placebo (n=2) x 1 day

Drug: LB-102

Part A Cohort 2

ACTIVE COMPARATOR

LB-102 15 mg (n=6) or Matching Placebo (n=2) x 1 day

Drug: LB-102

Part A Cohort 3

ACTIVE COMPARATOR

LB-102 100 mg (n=6) or Matching Placebo (n=2) x 1 day

Drug: LB-102

Part A Cohort 4

ACTIVE COMPARATOR

LB-102 200 mg (n=6) or Matching Placebo (n=2) x 1 day

Drug: LB-102

Part A Cohort 5

ACTIVE COMPARATOR

LB-102 150 mg (n=6) or Matching Placebo (n-2) x 1 day

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)

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)

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)

Drug: LB-102

Interventions

LB-102 DRUG

(N-Methyl amisulpride)

Also known as: Active 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

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• LB Pharmaceuticals Inc.: lead

Study Sites (1)

Medpace Clinical Pharmacology LLC

Cincinnati, Ohio, 45227, United States

Location

Related Links

• Corporate Website

MeSH Terms

Conditions

Schizophrenia

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Lukasz Biernat, MD

  Medpace, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: January 22, 2020
• Primary Completion: July 1, 2020
• Study Completion: November 9, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)