Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01375387
First received: April 19, 2011
Last updated: August 19, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers |
Drug: Lacosamide Other: Placebo 3 Other: Placebo 4 Other: Placebo 2 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Maximum drug concentration (Cmax) of lacosamide in plasma. [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to reach maximum plasma concentration (tmax) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Terminal half-life (t½) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Apparent total body clearance (CL/F) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Apparent volume of distribution (Vz/F) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Mean resident time (MRT) of lacosamide in plasma. [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- First order terminal elimination rate constant (λZ ) of lacosamide in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Maximum drug concentration (Cmax) of SPM12809 in plasma. [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Terminal half-life (t½) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- First order terminal elimination rate constant (λZ ) of SPM12809 in plasma [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809 [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Fraction of dose excreted in urine (fe) of lacosamide and SPM12809 [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Renal clearance (CLR) of lacosamide and SPM12809 [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- Apparent formation clearance of metabolites (CLfm/F) [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
- AUC Ratio [ Time Frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | March 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lacosamide 100 mg, Japanese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
|
Drug: Lacosamide
100 mg oral tablet, single dose
Other Name: Vimpat®
Other: Placebo 3
Placebo - 3 tablets
|
|
Experimental: Lacosamide 100 mg, Chinese
1 Lacosamide 100 mg tablet plus 3 placebo tablets
|
Drug: Lacosamide
100 mg oral tablet, single dose
Other Name: Vimpat®
Other: Placebo 3
Placebo - 3 tablets
|
|
Experimental: Lacosamide 200 mg, Japanese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
|
Drug: Lacosamide
Lacosamide 2 X 100 mg tablet
Other Name: Vimpat®
Other: Placebo 2
Placebo - 2 tablets
|
|
Experimental: Lacosamide 200 mg, Chinese
2 Lacosamide 100 mg tablets plus 2 placebo tablets
|
Drug: Lacosamide
Lacosamide 2 X 100 mg tablet
Other Name: Vimpat®
Other: Placebo 2
Placebo - 2 tablets
|
|
Experimental: Lacosamide 400 mg, Japanese
4 Lacosamide 100 mg tablets
|
Drug: Lacosamide
Lacosamide 4 X 100mg tablet
Other Name: Vimpat®
|
|
Experimental: Lacosamide 400 mg, Chinese
4 Lacosamide 100 mg tablets
|
Drug: Lacosamide
Lacosamide 4 X 100mg tablet
Other Name: Vimpat®
|
|
Placebo Comparator: Placebo Comparator, Japanese
4 placebo tablets
|
Other: Placebo 4
Placebo - 4 tablets
|
|
Placebo Comparator: Placebo Comparator, Chinese
4 placebo tablets
|
Other: Placebo 4
Placebo - 4 tablets
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT01375387 History of Changes |
| Other Study ID Numbers: | SP1046, 2010-023164-40 |
| Study First Received: | April 19, 2011 |
| Last Updated: | August 19, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by UCB, Inc.:
|
Vimpat Pharmacokinetics Healthy Japanese male Healthy Chinese male |
ClinicalTrials.gov processed this record on June 17, 2013