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

• Sponsor: UCB Biopharma S.P.R.L. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02972125
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 3.9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) dry syrup	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ep0059 001	London		United Kingdom

Sponsors and Collaborators

• UCB Biopharma S.P.R.L.

Investigators

• Study Director: UCB Cares, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: UCB Biopharma S.P.R.L.
• ClinicalTrials.gov Identifier: NCT02972125
• Other Study ID Numbers: EP0059; 2016-002462-31
• First Posted: Nov 23, 2016
• Last Update Posted: Mar 10, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by UCB Biopharma S.P.R.L.: Lacosamide; Bioequivalence; Dry Syrup
• Additional relevant MeSH terms: Lacosamide

Study Results

No Results Posted as of Mar 10, 2017