A Phase I, Randomized Double-blind, Placebo-controlled, Single-center, Single-dose, Three-way Cross-over Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lacosamide Tablets in Healthy Male Chinese and Japanese Subjects
Overview
- Phase
- Phase 1
- Intervention
- Lacosamide
- Conditions
- Healthy Volunteers
- Sponsor
- UCB Pharma
- Enrollment
- 33
- Primary Endpoint
- Maximum drug concentration (Cmax) of lacosamide in plasma.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Chinese or Japanese volunteers
Exclusion Criteria
- •Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
- •Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)
Arms & Interventions
Lacosamide 100 mg, Japanese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
Intervention: Lacosamide
Lacosamide 100 mg, Japanese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
Intervention: Placebo 3
Lacosamide 100 mg, Chinese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
Intervention: Lacosamide
Lacosamide 100 mg, Chinese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
Intervention: Placebo 3
Lacosamide 200 mg, Japanese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
Intervention: Lacosamide
Lacosamide 200 mg, Japanese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
Intervention: Placebo 2
Lacosamide 200 mg, Chinese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
Intervention: Lacosamide
Lacosamide 200 mg, Chinese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
Intervention: Placebo 2
Lacosamide 400 mg, Japanese
4 Lacosamide 100 mg tablets
Intervention: Lacosamide
Lacosamide 400 mg, Chinese
4 Lacosamide 100 mg tablets
Intervention: Lacosamide
Placebo Comparator, Japanese
4 placebo tablets
Intervention: Placebo 4
Placebo Comparator, Chinese
4 placebo tablets
Intervention: Placebo 4
Outcomes
Primary Outcomes
Maximum drug concentration (Cmax) of lacosamide in plasma.
Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma
Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma
Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Secondary Outcomes
- Time to reach maximum plasma concentration (tmax) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Terminal half-life (t½) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Apparent total body clearance (CL/F) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Apparent volume of distribution (Vz/F) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Mean resident time (MRT) of lacosamide in plasma.(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- First order terminal elimination rate constant (λZ ) of lacosamide in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Maximum drug concentration (Cmax) of SPM12809 in plasma.(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Terminal half-life (t½) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- First order terminal elimination rate constant (λZ ) of SPM12809 in plasma(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Fraction of dose excreted in urine (fe) of lacosamide and SPM12809(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Renal clearance (CLR) of lacosamide and SPM12809(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- Apparent formation clearance of metabolites (CLfm/F)(Multiple sampling from 0 to 72 hours following single dose in each treatment period)
- AUC Ratio(Multiple sampling from 0 to 72 hours following single dose in each treatment period)