epilepsy / seizures
Conditions
Interventions
Subjects will receive UCB0942 BID (given orally as a suspension) on Days 1
through 12 according to the following schedule:
Day 1: 100 mg BID
Day 2 and 3: 200 mg BID
Day 4 to 8: 400 mg BID
Day 9 and
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is between 18 to 64 years of age, inclusive, with a diagnosis of epilepsy 2. Subject is currently treated for epilepsy with stable doses of carbamazepine (at least 600mg/day), lamotrigine (at least 150mg/day), or levetiracetam (at least 1g/day) as monotherapy for at least 3 months. 3. Subject taking CBZ has trough CBZ plasma level in the target range (4 to 12*g/mL) and CBZ-epoxide plasma level * 4*g/mL. 4. Subject is in good physical and mental health. 5. Subject has clinical laboratory test results within the reference ranges of the laboratory. 6. Subject has a body mass index (BMI) of 18 to 35kg/m², inclusive, with a body weight of at least 50kg (male) or 45kg (female). 7. Subject smokes
Exclusion criteria
Exclusion criteria: 1. Subject has participated in another study of an investigational medication (or a medical device) within the last 3 months. 2. Subject has a known hypersensitivity to any components of UCB0942 3. Subject has a current or past medical or psychiatric condition that could jeopardize or would compromise her/his ability to participate in this study. 4. Subject has a history of status epilepticus during the last year. 5. Subject has a history or presence of drug or alcoho dependency or tests positive for alcohol and/or drugs at Screening or Day -1. 6. Subject has an alcohol consumption of more than 28 units of alcohol per week. 7. Subject has a consumption of more than 600mg of caffeine/day. 8. Subject has a history or present condition of hepatic disorders. 9. Subject has had significant blood loss or has donated blood within 30 days prior to the study. 10. Subject has a history or present condition of respiratory or cardiovascular disorders. 11. Subject has a clinically significant abnormality in the 12-lead ECG and/or 48h Holter ECG. 12. Subject has a history of unexplained syncope or a family history of sudden death due to long QT syndrome. 13. Subject tests positive HIV, hepatitis B, or hepatitis C. 14. Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months. 15. Subject is a female and has a positive pregnancy test. 16. Subject has received prescription or nonprescription medicines (with a few described exceptions) within 14 days the study. 17. Subject has consumed any grapefruit containing products, or star fruit within 14 days prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough plasma concentrations of CBZ-epoxide The ratio of trough concentrations of CBZ-epoxide to the trough concentration of CBZ | — |
Secondary
| Measure | Time frame |
|---|---|
| UCB0942 and its identified metabolites * PK parameters: Cmax, tmax, AUC, and CLss/F (only for UCB0942) AEDs *Trough plasma concentrations of CBZ, LTG, and LEV Cortisol and beta-OHC in 24-hour urine prior to first dose and after final 400 mg dose. Adverse events Vital signs (pulse rate [PR], respiratory rate [RR], systolic blood pressure [SBP], and diastolic blood pressure [DBP]) 12-lead ECG and Holter ECG parameters Physical examination findings Clinical laboratory test results (hematology, clinical chemistry, and urinalysis) | — |
Countries
Netherlands
Outcome results
None listed