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

NCT03695094 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-06-04

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-05-18
Completion
2019-05-30

Countries

  • Bulgaria
  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03695094 on ClinicalTrials.gov