An Open-Label Interaction Study to Look at the Effects of Brivaracetam on Phenytoin When Taken Together in 15 Adult Patients With Epilepsy.
The primary objective of this Phase I study in 15 adult subjects suffering from epilepsy and chronically treated with phenytoin monotherapy is to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Open-Label, Unilateral Interaction Study of Ucb 34714 on Stable Phenytoin Monotherapy During a 45 Day b.i.d. Administration Period in 15 Adult Subjects Suffering From Epilepsy|
- to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
- Blood samples for PK calculations collected at different time points, on Visit 2 and Visit 7, for determination of phenytoin plasma concentrations (Phenytoin levels at pre-dose, 1, 2, 4, 6, 8, 12 (24 if PHT od) hours at V2 and V7)
- The drug interaction on phenytoin will be assessed by comparison of AUCτ and Cmax between Visit 2 (phenytoin alone) and Visit 7 (combination of ucb 34714 and phenytoin).
- information on the tolerability and safety of the simultaneous administration of ucb 34714 and phenytoin in epilepsy patients.
|Study Start Date:||April 2005|
|Study Completion Date:||June 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
|United States, Arkansas|
|Little Rock, Arkansas, United States|
|United States, Virginia|
|Charlottesville, Virginia, United States|
|United States, Wisconsin|
|Madison, Wisconsin, United States|
|Study Director:||Philipp von Rosenstiel, M.D.||UCB, Inc.|