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

Phase 1CompletedNCT03204474

UCB Biopharma S.P.R.L.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Male Chinese Volunteers

Interventions

Lacosamide (LCM) tabletDRUG

Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

Lacosamide (LCM) solution for infusionDRUG

Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sp1043 001

Shanghai, China

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of Lacosamide (LCM)

Blood samples will be taken at indicated time points to determine maximum Lacosamide (LCM) plasma concentration.

Time frame: 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.

Time frame: 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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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