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Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986608
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Brief Summary:
This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Lacosamide infusion Drug: Lacosamide oral Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single Center Open-label, Randomized, Single-dose, 3-way Crossover Study to Compare the Safety, Tolerability, and Pharmacokinetics of Lacosamide Administered as Oral Tablet or Intravenous Infusion in Healthy Japanese Subjects
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide 30-minute iv
A 30-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).
Drug: Lacosamide infusion

Strength: 10 mg/mL for infusion

Form: solution for infusion

Dosage: 200 mg, single dose

Duration: 30-minute infusion or 60-minute infusion

Other Name: Vimpat

Experimental: Lacosamide 60-minute iv
60-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).
Drug: Lacosamide infusion

Strength: 10 mg/mL for infusion

Form: solution for infusion

Dosage: 200 mg, single dose

Duration: 30-minute infusion or 60-minute infusion

Other Name: Vimpat

Experimental: Lacosamide oral tablet
Oral administration of Lacosamide (LCM) 200 mg (2 x 100 mg film-coated tablet) with 200 mL of water.
Drug: Lacosamide oral

Strength: 200 mg

Form: film-coated tablet

Dosage: 200 mg, single dose

Duration: single oral intake

Other Name: Vimpat




Primary Outcome Measures :
  1. Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  2. Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of Lacosamide (AUC 0-t) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]

Secondary Outcome Measures :
  1. Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  2. Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  3. Mean residence time (MRT) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  4. Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  5. Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  6. Apparent total body clearance (CL/F) after oral administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  7. Total body clearance (CL) after intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  8. Apparent volume of distribution (Vz/F) after oral administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]
  9. Volume of distribution (Vz) after intravenous administration of Lacosamide [ Time Frame: Pharmacokinetic samples will be taken at predose/preinfusion, 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 postdose (start of infusion) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion Criteria:

  • Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months
  • Subject has a history (within 6 months) before screening visit of chronic alcohol and/or drug abuse and/or has smoked and/or has a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, or neurological disorders
  • Subject has a history of suicide attempt or current active suicidal ideation
  • Subject has experienced a myocardial infarction and/or made a blood donation or any other blood loss more than 400 ml in the last 3 months
  • Subject is pregnant or nursing
  • Subject is not healthy (eg, taking any drug treatments, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters and/or was positive for HIV, HBsAg, HCV)
  • Subject has an excessive use of alcohol or/and cigarettes and/or caffeine and/or abnormal diet and/or has taken grapefruit or grapefruit drink within 7 days before intake of Investigational Medicinal Product (IMP)
  • Subject has a clinically significant abnormality in the 12-lead Electrocardiogram (ECG)
  • Subject is having clinically relevant drug hypersensitivity to any components of the investigational medicinal product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986608


Locations
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United Kingdom
001
Harrow, Middlesex, United Kingdom
Sponsors and Collaborators
UCB Pharma SA
Investigators
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
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Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT01986608    
Other Study ID Numbers: EP0036
2012-003084-21 ( EudraCT Number )
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by UCB Pharma ( UCB Pharma SA ):
Lacosamide
Vimpat
Bioequivalence
Bioavailability
Japanese
Additional relevant MeSH terms:
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Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action