A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

A Randomized, Open-Label, Single-Dose, 2-Way Crossover Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Male Chinese Volunteers
• Intervention / Treatment: Drug: Lacosamide (LCM) tablet; Drug: Lacosamide (LCM) solution for infusion

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Sp1043 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Subject is a Chinese male between 18 and 40 years of age
• Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
• Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used

Exclusion Criteria:

Clinically relevant

• out of range values for hematology and clinical chemistry variables
• abnormality in physical examination or vital signs
• ECG finding

Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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) 200 mg administered as 2 oral tablets [100 mg each]), 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 200 mg administered as intravenous infusion)	Drug: Lacosamide (LCM) tablet; Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg; Other Names: Vimpat; Drug: Lacosamide (LCM) solution for infusion; Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion; Other Names: Vimpat
Experimental: Treatment B - A; Single administration of the test drug (Treatment B, a single dose of LCM 200 mg administered as intravenous infusion), 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) 200 mg administered as 2 oral tablets [100 mg each])	Drug: Lacosamide (LCM) tablet; Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg; Other Names: Vimpat; Drug: Lacosamide (LCM) solution for infusion; Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion; Other Names: Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax) of Lacosamide (LCM)	Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration.	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 LCM plasma concentration-time curve from time zero up to the time of last quantifiable concentration (AUC[0-t])	Area under the LCM plasma concentration-time curve from time zero up to the last quantifiable concentration data point, computed using the log-linear trapezoidal rule.	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 LCM plasma concentration-time curve extrapolated to infinity (AUC)	Area under the LCM plasma concentration-time curve extrapolated to infinity calculated as AUC(0-t) + t/z, where t is the estimated plasma concentration at time t and z the terminal elimination rate constant.	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	Measure Description	Time Frame
Terminal plasma elimination half-life (t1/2) of LCM	Terminal elimination half-life of LCM, reported in hours, as determined via simple linear regression (slope=-z) of natural log (ln) concentration vs time for data points in the terminal phase of the concentration-time curve. t½ is calculated as ln(2)/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
Time of observed Cmax (tmax) of LCM	Time of observed Cmax will be obtained directly from the plasma concentration-time curves.	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 plasma clearance (CL/F) of LCM	Apparent plasma clearance calculated as CL/F=Dose/AUC. CL/F will be calculated for the oral tablet formulation only	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) of LCM	Apparent volume of distribution, calculated as Vz/F=(CL/F)/z. Vz/F will be calculated for the oral tablet formulation only	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
Plasma clearance (CL) of LCM	Plasma clearance, calculated as CL=Dose/AUC. CL will be calculated for the iv formulation only.	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
Volume of distribution (Vz) of LCM	Volume of distribution, calculated as Vz=CL/z. Vz will be calculated for the iv formulation only.	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 (Actual): June 8, 2017
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: June 29, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Bioequivalence; Lacosamide; Tablet; Intravenous solution
• 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: SP1043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No