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OpenTrials
Completed

NCT Number: NCT01986608

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

001

Harrow, Middlesex, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide infusion

Drug

Strength: 10 mg/mL for infusion

Form: solution for infusion

Dosage: 200 mg, single dose

Duration: 30-minute infusion or 60-minute infusion

Other names: Vimpat

Lacosamide oral

Drug

Strength: 200 mg

Form: film-coated tablet

Dosage: 200 mg, single dose

Duration: single oral intake

Other names: Vimpat

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

UCB Pharma SA

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 18, 2013
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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