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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
(N-Methyl amisulpride)
Medpace Clinical Pharmacology LLC
Cincinnati, Ohio, United States
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.
Time frame: Day 8 (Part A) or Day 15 (Part B)
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).
Time frame: 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).
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
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)
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
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).
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Time frame: Days 1, 2 and 3 (Part A) Days 1 through 9 (Part B)