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

NCT01450111 | Completed Phase 1

• 1 other identifier: SP0952
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy

Keywords

Lacosamide

Outcome Measures

Primary Outcomes (4)

• Maximum concentration of lacosamide at steady state (Cmax) during up to 9 days of administration

  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)

• Time of maximum plasma concentration (Tmax) during up to 9 days of administration

  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)

• Area under the plasma concentration curve (AUC) during up to 9 days of administration

  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)

• The fraction of drug excreted unchanged in urine (Fe) during up to 9 days of administration

  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

Secondary Outcomes (2)

• Apparent clearance (CL/F)

  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)

• Apparent volume of distribution (V/F)

  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)

Study Arms (6)

Lacosamide 50 mg group

EXPERIMENTAL

Lacosamide 50 mg tablet, once a day per os (po)

Drug: Lacosamide

Placebo group matched with lacosamide 50 mg

PLACEBO COMPARATOR

Placebo matched with lacosamide 50 mg tablet, po

Other: Placebo

Lacosamide 100 mg group

EXPERIMENTAL

Lacosamide 100 mg tablet, po

Drug: Lacosamide

Placebo group matched with lacosamide 100 mg

PLACEBO COMPARATOR

Placebo matched with lacosamide 100 mg tablet, po

Other: Placebo

Lacosamide 200 mg group

EXPERIMENTAL

Lacosamide 200 mg tablet, po

Drug: Lacosamide

Placebo group matched with lacosamide 200 mg

PLACEBO COMPARATOR

Placebo matched with lacosamide 200 mg tablet, po

Other: Placebo

Interventions

Lacosamide DRUG

Lacosamide 50 mg, tablet, once in the morning on Day 1

Also known as: Vimpat®

Lacosamide 50 mg group

Placebo OTHER

Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1.

Placebo group matched with lacosamide 50 mg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

MeSH Terms

Conditions

Epilepsy

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: November 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 14, 2011

Record last verified: 2011-10