Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375387

Locations
Germany
Neuss, Germany
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  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

Additional relevant MeSH terms:
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014