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

UCB Pharma0 sites15 target enrollmentApril 2005

ConditionsEpilepsy

DrugsBrivaracetam (ucb34714)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Epilepsy
Sponsor: UCB Pharma
Enrollment: 15
Primary Endpoint: to evaluate the effect of steady-state ucb 34714 administration on the steady-state plasma levels of phenytoin.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

June 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

UCB Pharma

Eligibility Criteria

Inclusion Criteria

•Well-characterized epileptic syndrome according to the ILAE classification.
•Patients currently treated with stable phenytoin monotherapy for at least three months and with at least one plasma measurement of pheyntoin within the target range (7 - 23 µg/ml) during the screening period.

Exclusion Criteria

•History of status epilepticus in the last year.
•Subjects taking any drug that may significantly influence the metabolism of ucb 34714 (CYP2C or CYP3A potent inducers/inhibitors) except if the dose has been stable at least three months before entry into the study and will be kept stable for the entire trial duration.
•Subjects with a creatinine clearance of ≤50 mL/min.

Outcomes

Primary Outcomes

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).