To Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01450111
First received: October 7, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

Primary objective of this trial was to investigate the pharmacokinetics of single dose and repeated dose applications of lacosamide in healthy male Korean subjects.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single/Repeated Dose Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Maximum concentration of lacosamide at steady state (Cmax) during up to 9 days of administration [ Time Frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) ] [ Designated as safety issue: No ]
  • Time of maximum plasma concentration (Tmax) during up to 9 days of administration [ Time Frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) ] [ Designated as safety issue: No ]
  • Area under the plasma concentration curve (AUC) during up to 9 days of administration [ Time Frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) ] [ Designated as safety issue: No ]
  • The fraction of drug excreted unchanged in urine (Fe) during up to 9 days of administration [ Time Frame: Urine samples were collected 0 - 4 hr, 4 - 8 hr, 8 - 12 hr, 12 - 24 hr, 24 - 48 hr, 48 - 72 hr, 72 - 96 hr after administration at Day 1 and Day 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apparent clearance (CL/F) [ Time Frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) ] [ Designated as safety issue: No ]
  • Apparent volume of distribution (V/F) [ Time Frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8) ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide 50 mg group
Lacosamide 50 mg tablet, once a day per os (po)
Drug: Lacosamide
Lacosamide 50 mg, tablet, once in the morning on Day 1
Other Name: Vimpat®
Placebo Comparator: Placebo group matched with lacosamide 50 mg
Placebo matched with lacosamide 50 mg tablet, po
Other: Placebo
Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1.
Experimental: Lacosamide 100 mg group
Lacosamide 100 mg tablet, po
Drug: Lacosamide
Lacosamide 100 mg, tablet, once in the morning on Day 1 Lacosamide 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
Other Name: Vimpat®
Placebo Comparator: Placebo group matched with lacosamide 100 mg
Placebo matched with lacosamide 100 mg tablet, po
Other: Placebo
Placebo matched with Lacosamide 100 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamode 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
Experimental: Lacosamide 200 mg group
Lacosamide 200 mg tablet, po
Drug: Lacosamide
Lacosamide 200 mg, tablet, once in the morning on Day 1 Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
Other Name: Vimpat®
Placebo Comparator: Placebo group matched with lacosamide 200 mg
Placebo matched with lacosamide 200 mg tablet, po
Other: Placebo
Placebo matched with Lacosamide 200 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is healthy male and between 20 and 45 years of age (inclusive)
  • Subject has no clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
  • Subject is of normal body weight as determined by a body mass index (BMI) between 19 and 28 kgm^2
  • Subject is Korean (both parents are of pure Korean ethnicity)

Exclusion Criteria:

  • Subject has a history of or present psychiatric or neurological condition that, in the opinion of the Investigator, could jeopardize or would have compromised the subject's ability to participate in this trial
  • Subject has a known or suspected drug hypersensitivity, in particular to the trial medication
  • Subject consumes more than 40 g alcohol/day (amount corresponds to 1 L beer/day or 0.5 L wine/day or 6 glasses (à 2cL) liquor/day)
  • Subject has donated blood or had a comparable blood loss (>400 mL) within the last 3 months prior to Eligibility Assessment (EA)
  • Subject smokes more than 5 cigarettes per day or had done so within 6 months prior to EA.
  • Subject consumes more than 600 mg caffeine/day (200 mL coffee contain approximately 100 mg caffeine, 200 mL black tea approximately 30 mg, and 200 mL cola approximately 20 mg)
  • Subject has a diet which deviates notably from the "normal" amounts of protein, carbohydrate, and fat, as judged by the Investigator (eg, vegetarians or vegans)
  • Subject has taken herbal medicine therapy within 2 weeks prior to the first dosing
  • Subject has a clinically relevant allergy
  • Subject is taking any concomitant medication currently or within 2 weeks prior to the first dosing (with the exception of acetaminophen which is allowed to be taken orally up to 1000 mg per dose up to 48 hours prior to commencement of dosing)
  • Subject has positive tests for alcohol and/or drugs (urine test) at EA and at confinement
  • Subject has a high risk behavior for the HIV
  • Subject is tested to be positive for HIV antibodies (HIV Ab), hepatitis B surface antigen (HBs Ag), or hepatitis C virus antibody (HCV Ab)
  • Subject has a history or present condition of hepatic disorders, eg, clinically relevant liver enzyme increase (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [AP], and gamma-glutamyl transpeptidase [GGT])
  • Subject has a transaminase (either ALT or AST) more than 2 times of the upper limit of normal range (ULN) at confinement
  • Subject has clinically relevant out-of-range values for hematology including coagulation parameters, and clinical chemistry, serology or urinalysis parameters
  • Subject has any clinically relevant abnormality in the physical examination or vital signs
  • Subject has a pulse rate at rest less than 45 bpm or more than 100 bpm at EA
  • Subject has a systolic blood pressure lower than 100 mmHg or higher than 160 mmHg or a diastolic blood pressure higher than 95 mmHg at EA
  • Subject has clinically relevant findings in the ECG, such as second or third degree atrioventricular (AV) block or PR interval >220 ms, prolongation of the QRS duration to >110 ms, or a QTcB (Bazett corrected) interval over 450 ms or any other clinically relevant ECG finding at EA
  • Subject performed heavy physical exertion 2 days before EA or before confinement
  • Subject has a history or present condition of respiratory or cardiovascular disorders, eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or status after myocardial infarction
  • Subject has a history or present condition of malignancy
  • Subject has a history or present condition of seizure disorder
  • Subject has atrial fibrillation/flutter, ventricular tachyarrhythmia (eg, ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest), symptomatic heart block at Eligibility Assessment Visit, or is diagnosed with Brugada syndrome (also known as Sudden Unexpected Death Syndrome)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450111

Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01450111     History of Changes
Other Study ID Numbers: SP0952
Study First Received: October 7, 2011
Last Updated: October 13, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by UCB, Inc.:
Lacosamide

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014