Abstract Details

Title Safety, Tolerability, and Pharmacokinetics of ET-105, Lamotrigine for Oral Suspension, Under Fasting and Fed Conditions

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-003

Objective To evaluate the pharmacokinetic properties of ET-105 (lamotrigine for oral suspension) compared to the reference compound (Lamictal^® tablets) under fasting conditions and evaluate the effect of food on ET-105 pharmacokinetics.

Background Lamotrigine, currently available in tablet form, is a broad spectrum anti-epileptic drug that has multiple indications for treatment of seizures in adults and children. ET-105 is a novel formulation of lamotrigine designed to improve dosing precision in pediatric patients and those with dysphagia.

Design/Methods In this single-center, 3-way crossover study, 24 healthy subjects ≥18 years old were assigned to receive, in random order, single doses of 5 mL of 10 mg/mL ET-105 under fasting conditions, 2 x 25 mg lamotrigine tablets under fasting conditions, or 5 mL of 10 mg/mL ET-105 under fed conditions (30 minutes after a meal), with a 21-day washout period between doses. Blood samples were collected pre-dose and up to 216 hours post-dose. Treatment-related adverse events (TEAEs) were monitored throughout the study.

Results All subjects received ≥1 dose of study drug; 22 subjects completed the study. Under fasting conditions, there were no significant differences between the geometric least-square means (LSM) of ET-105 and the reference compound for AUC_0-tau(p=0.78), AUC_0-infinity(p=0.73), and C_max (p=0.13). Comparison of ET-105 under fed versus fasting conditions showed delay in T_max of approximately 3 hours and significant decrease in C_max (p<0.001), however, the 90% geometric confidence intervals of the ratio of LSM for AUC_0-tau, AUC_0-infinity, and C_max were within the per protocol acceptance range (80-125%) to demonstrate bioequivalence. All TEAEs experienced in all cohorts were reported to be mild in nature; 1 patient discontinued treatment due to a TEAE.

Conclusions The administration of ET-105, lamotrigine for oral suspension, was safe and well tolerated in healthy subjects under fasting and fed conditions and is bioequivalent to reference lamotrigine tablets.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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