A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

A Single-Center, Open-Label, Randomized, Single-Oral Dose, 2-Way Cross-Over Study to Investigate the Bioequivalence Between Lacosamide Tablet and Dry Syrup in Healthy Male Japanese Subjects

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) dry syrup

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Ep0059 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject is male and between 20 and 55 years of age (inclusive)
• Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
• Male subject confirms that when having sexual intercourse with a woman of childbearing potential, he will use condoms during the study and 1 week after the last dose of study drug

Exclusion Criteria:

• Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
• Subject has clinically relevant out-of-range values for hematology, and serum chemistry, or urinalysis variables at the Screening Visit.
• Subject has any clinically significant abnormal physical examination (Screening Visit or Day -1) and vital signs (Screening Visit).
• Subject has any clinically relevant ECG finding at the Screening Visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A - B; Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup).	Drug: Lacosamide (LCM) tablet; Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet; Drug: Lacosamide (LCM) dry syrup; Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup
Experimental: Treatment B - A; Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet).	Drug: Lacosamide (LCM) tablet; Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet; Drug: Lacosamide (LCM) dry syrup; Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
Area under the curve from 0 to time of last quantifiable concentration (AUC(0-t))	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the curve from zero up to infinity (AUC)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
Apparent total body clearance (CL/F)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
Apparent volume of distribution (Vz/F)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
Mean residence time (MRT)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
Time of observed Cmax (tmax)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
Terminal elimination half-life (t1/2)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing
First order terminal elimination rate constant (Lambda z)	Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Bioequivalence; Lacosamide; Dry Syrup
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: EP0059; 2016-002462-31 (EudraCT Number)