A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Padsevonil; Oxcarbazepine; Levetiracetam; Lamotrigine; Brivaracetam
Intervention description: Padsevonil (PSL) will be dosed to steady state and the effect of background therapies on pharmacokinetics will be assessed; Concomitant administration of oxcarbazepine (OXC) at therapeutic dosage; Concomitant administration of levetiracetam (LEV) at therapeutic dosage; Concomitant administration of lamotrigine (LTG) at therapeutic dosage; Concomitant administration of brivaracetam (BRV) at therapeutic dosage
Intervention MeSH terms: Lamotrigine; Oxcarbazepine; Levetiracetam; Brivaracetam; Padsevonil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Epilepsy; Phase 1; padsevonil

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study participant is male or female between 18 to 64 years of age, inclusive, with a
             diagnosis of epilepsy according to the International League Against Epilepsy (ILAE)
             classification

          -  Study participant is currently treated for epilepsy with stable doses of the following
             for at least 3 months:

               1. Inducers Group: Oxcarbazepine (OXC) (at least 1200 mg/day as monotherapy or in
                  combination with brivaracetam (BRV) [up to 200 mg/day], levetiracetam (LEV) [at
                  least 1 g/day] or lamotrigine (LTG) [at least 150 mg/day]); or

               2. Neutral (control) Group: LTG (at least 150 mg/day monotherapy or adjunctive to
                  LEV or BRV), LEV (at least 1 g/day monotherapy or adjunctive to LTG), or BRV (up
                  to 200 mg/day adjunctive to LTG)

          -  Study participant in the Inducers Group is taking OXC and has a trough OXC metabolite
             Mono Hydroxy Derivate (MHD) plasma level in the target range (≥12.0 to ≤35.0 mcg/mL)

          -  Study participant has clinical laboratory test results within the local reference
             ranges or values are considered as not clinically relevant by the Investigator and
             approved by the UCB Study Physician

          -  Study participant has a body mass index (BMI) of 18 to 35 kg/m², inclusive, with a
             body weight of at least 50 kg (male) or 45 kg (female)

          -  Female study participant has a negative serum pregnancy test at the Screening Visit
             and agrees to use an efficient form of contraception for the duration of the study
             (unless menopausal [defined as no menses for 12 months without an alternative medical
             cause]; a high follicle-stimulating hormone level in the postmenopausal range may be
             used to confirm a postmenopausal state in women not using hormonal contraception or
             hormonal replacement therapy). -Male study participant agrees that, during the study
             period, when having sexual intercourse with a woman of childbearing potential, he will
             use an efficient barrier contraceptive (condom plus spermicide) AND that the
             respective partner will use an additional efficient contraceptive method (eg, oral
             pills, intrauterine device, intrauterine hormone-releasing systems, or diaphragm, and
             spermicide)

        Exclusion Criteria:

          -  Study participant has participated in another study of an investigational medication
             (or a medical device) within the last 3 months before screening (or 5 half-lives,
             whichever is longer) or is currently participating in another study of an
             investigational medication (or a medical device)

          -  Study participant has a known hypersensitivity to any components of the IMP as stated
             in this protocol

          -  Study participant has any medical condition that, in the opinion of the Investigator,
             could jeopardize or would compromise the study participant's ability to participate in
             this study

          -  Study participant has a history of status epilepticus during the last year

          -  Study participant has any clinically relevant electrocardiogram (ECG) finding at the
             Screening Visit or at Baseline

          -  Study participant has received any prescription or nonprescription medicines,
             including enzyme inhibitors or inducers, over the counter (OTC) remedies, herbal and
             dietary supplements (including St. John's Wort), or vitamins up to 2 weeks or 5
             half-lives of the respective drug (whichever is longer) before the first
             administration of IMP and during the clinical part of the study, unless required to
             treat an Adverse event (AE). This does not include allowed antiepileptic drugs (AEDs)
             per the protocol, oral contraceptives not exceeding 30 μg ethinyl estradiol or
             postmenopausal hormone replacement therapy or implants, patches, or IUDs/IUSs
             delivering progesterone (for female study participants)