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
Overview
- Phase
- Phase 1
- Intervention
- Lacosamide
- Conditions
- Epilepsy
- Sponsor
- UCB Pharma
- Enrollment
- 51
- Primary Endpoint
- Maximum concentration of lacosamide at steady state (Cmax) during up to 9 days of administration
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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)
Arms & Interventions
Lacosamide 50 mg group
Lacosamide 50 mg tablet, once a day per os (po)
Intervention: Lacosamide
Placebo group matched with lacosamide 50 mg
Placebo matched with lacosamide 50 mg tablet, po
Intervention: Placebo
Lacosamide 100 mg group
Lacosamide 100 mg tablet, po
Intervention: Lacosamide
Placebo group matched with lacosamide 100 mg
Placebo matched with lacosamide 100 mg tablet, po
Intervention: Placebo
Lacosamide 200 mg group
Lacosamide 200 mg tablet, po
Intervention: Lacosamide
Placebo group matched with lacosamide 200 mg
Placebo matched with lacosamide 200 mg tablet, po
Intervention: Placebo
Outcomes
Primary Outcomes
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)
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)
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)
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
Secondary Outcomes
- 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))