NCT03695094

A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil

A Multicenter, Open-label, Parallel-group Study in Study Participants With Epilepsy, to Evaluate the Effect of Oxcarbazepine on the Pharmacokinetics, Safety, and Tolerability of Padsevonil

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effect of stable coadministered oxcarbazepine (OXC), on the pharmacokinetics (PK), safety, tolerability of padsevonil (PSL) and the plasma PK of PSL metabolites, UCB1431322-000 and UCB1447499-000, in study participants with epilepsy compared with study participants co-medicated with stable doses of levetiracetam (LEV), lamotrigine (LTG) or brivaracetam (BRV) therapy.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Padsevonil	Padsevonil (PSL) will be dosed to steady state and the effect of background therapies on pharmacokinetics will be assessed
DRUG	Oxcarbazepine	Concomitant administration of oxcarbazepine (OXC) at therapeutic dosage
DRUG	Levetiracetam	Concomitant administration of levetiracetam (LEV) at therapeutic dosage
DRUG	Lamotrigine	Concomitant administration of lamotrigine (LTG) at therapeutic dosage
DRUG	Brivaracetam	Concomitant administration of brivaracetam (BRV) at therapeutic dosage

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-05-18
• Completion: 2019-05-30
• First posted: 2018-10-03
• Last updated: 2020-06-04
• Results posted: 2020-06-04

Locations

2 sites across 2 countries: Bulgaria, Netherlands