Abstract Details

Title Single Ascending Dose Pharmacokinetics (PK), Pharmacodynamics (PD), and Tolerability of LP352 in Healthy Subjects

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P14 - Poster Session 14 (11:45 AM-12:45 PM)

Poster/Presentation
Number 10-001

Objective

To evaluate the PK, PD, safety and tolerability of single doses of LP352 administered to healthy subjects.

Background LP352 is a potent and selective 5-HT2c superagonist. LP352 is being developed for the treatment of developmental and epileptic encephalopathies (DEEs).

Design/Methods

This was a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy adults, ages 18 to 55 years and body mass index (BMI) of 18.5-30.0 kg/m². Subjects were randomized to receive single doses of powder in capsule formulation, under fasting conditions. Each cohort consisted of 6 active and 2 placebo subjects. Serial plasma and urine PK, and prolactin samples were collected up to 72 h. Safety was assessed continuously from signing of informed consent form through follow up visit.

Results Forty female subjects with mean age of 35.0 years and BMI of 24.0 kg/m² were enrolled. LP352 was rapidly absorbed with peak plasma concentrations occurring between 1 and 1.5 hours after dosing. The elimination half-life was approximately 5 to 7 hours. Peak and total exposure increased with dose, although the increase appears to be slightly greater than dose proportional especially at higher doses. Less than 5% of the administered dose (<5%) was eliminated renally. Thus, metabolism appears to be the major route of clearance. Prolactin increased within 2 h in a dose- and concentration-dependent manner. The most common treatment emergent adverse events were headache, postural dizziness, and nausea, which were mild to moderate in severity.

Conclusions Single doses of LP352 were safe and generally well tolerated.

Authors/Disclosures
Dolly A. Parasrampuria, PhD (Longboard Pharmaceuticals) PRESENTER	Dr. PARASRAMPURIA has received personal compensation for serving as an employee of Longboard Pharmaceutical. Dr. PARASRAMPURIA has received personal compensation for serving as an employee of Johnson & Johnson. Dr. PARASRAMPURIA has stock in Longboard Pharmaceuticals. Dr. PARASRAMPURIA has stock in Longboard Pharmaceuticals.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Philip Perera, MD	Dr. Perera has received personal compensation for serving as an employee of Longboard Pharmaceuticals. Dr. Perera has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Sage Therapeutics. Dr. Perera has stock in Longboard Pharmaceuticals. Dr. Perera has received personal compensation in the range of $100,000-$499,999 for serving as a Chief Medical Officer with Longboard Pharmaceuticals.

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