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

NCT01986608 | Completed Phase 1

• 2 other identifiers: EP00362012-003084-21
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Lacosamide; Vimpat; Bioequivalence; Bioavailability; Japanese

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide

  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)

• 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

  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 (9)

• Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide

  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)

• Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide

  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)

• Mean residence time (MRT) after oral and intravenous administration of Lacosamide

  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)

• Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide

  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)

• Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide

  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)

Study Arms (3)

Lacosamide 30-minute iv

EXPERIMENTAL

A 30-minute intravenous constant infusion of Lacosamide (LCM) 200 mg (200 mg/20 mL single-use vial).

Drug: Lacosamide infusion

Lacosamide 60-minute iv

EXPERIMENTAL

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

Drug: Lacosamide infusion

Lacosamide oral tablet

EXPERIMENTAL

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

Drug: Lacosamide oral

Interventions

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

Also known as: Vimpat

Lacosamide 30-minute iv; Lacosamide 60-minute iv

Lacosamide oral DRUG

Strength: 200 mg Form: film-coated tablet Dosage: 200 mg, single dose Duration: single oral intake

Also known as: Vimpat

Lacosamide oral tablet

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (1)

001

Harrow, Middlesex, United Kingdom

Location

MeSH Terms

Interventions

Lacosamide

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 18, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

GB (1)