LCM Oral and IV safety, tolerability and PK in Japanese participants.

• Research type

  Research Study

• Full title

  A single-center, open-label, randomised, single-dose, 3-way cross-over study to compare the safety, tolerability, and pharmacokinetics of lacosamide administered as oral tablet or intravenous infusion in healthy Japanese subjects.

• IRAS ID

  137691

• Eudract number

  2012-003084-21

• ISRCTN Number

  not provided

• Research summary

  The new medicine tested in this study is a compound called lacosamide. Lacosamide is being developed for treating partial onset seizures.

  Partial-onset seizures are seizures which affect only a part of the brain at onset. The brain is divided into 2 hemispheres, each consisting of 4 lobes. In partial seizures the seizure is generated in and affects just one part of the brain – the whole hemisphere or part of a lobe. Symptoms will vary according to where the seizure occurs.

  This study will recruit healthy, Japanese male and female participants between the ages of 20 and 55 years. A total of approximately 24 participants will take part in the study.

  This study will take place at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ.

  The purpose of the study is to compare the oral administered tablet form of lacosamide to the intravenous infusion administration form (two different infusion times) in healthy Japanese male and female participants.

  Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Plasma samples for pharmacokinetic (what the lacosamide does to the body) analysis will be collected.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/1389

• Date of REC Opinion

  7 Oct 2013

• REC opinion

  Favourable Opinion