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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972125
• Other study ID #: EP0059
• Secondary ID: 2016-002462-31
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2016
• Last updated: March 9, 2017
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet
• Lacosamide (LCM) dry syrup
Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Locations

Country	Name	City	State
United Kingdom	Ep0059 001	London

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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