Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT01375387
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 33
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lacosamide 200 mg, Chinese Placebo 2 2 Lacosamide 100 mg tablets plus 2 placebo tablets Lacosamide 100 mg, Japanese Placebo 3 1 Lacosamide 100 mg tablet plus 3 placebo tablets Lacosamide 100 mg, Chinese Placebo 3 1 Lacosamide 100 mg tablet plus 3 placebo tablets Lacosamide 200 mg, Japanese Placebo 2 2 Lacosamide 100 mg tablets plus 2 placebo tablets Placebo Comparator, Japanese Placebo 4 4 placebo tablets Placebo Comparator, Chinese Placebo 4 4 placebo tablets Lacosamide 100 mg, Japanese Lacosamide 1 Lacosamide 100 mg tablet plus 3 placebo tablets Lacosamide 100 mg, Chinese Lacosamide 1 Lacosamide 100 mg tablet plus 3 placebo tablets Lacosamide 200 mg, Japanese Lacosamide 2 Lacosamide 100 mg tablets plus 2 placebo tablets Lacosamide 200 mg, Chinese Lacosamide 2 Lacosamide 100 mg tablets plus 2 placebo tablets Lacosamide 400 mg, Japanese Lacosamide 4 Lacosamide 100 mg tablets Lacosamide 400 mg, Chinese Lacosamide 4 Lacosamide 100 mg tablets
- Primary Outcome Measures
Name Time Method Maximum drug concentration (Cmax) of lacosamide 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 lacosamide 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 lacosamide in plasma Multiple sampling from 0 to 72 hours following single dose in each treatment period
- Secondary Outcome Measures
Name Time Method 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