Epilepsy and epilepsy syndrome
Conditions
Sponsors
UCB Japan Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - The study participant must be 20 to 55 years of age inclusive, at the time of signing the informed consent. - The study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. - The study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage. - The study participant has a body weight >=50kg and body mass index within the range [18 to 30] kg/m2 (inclusive). - The study participant is male.
Exclusion criteria
Exclusion criteria: - The study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participants ability to participate in this study, such as a history of schizophrenia, or other psychotic disorder, bipolar disorder, or severe unipolar depression. The presence of potential psychiatric exclusion criteria will be determined based on the psychiatric history collected at the Screening Visit. - The study participant has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. - The study participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome. - The study participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response [Yes] to either Question 4 or Question 5 of the [Screening/Baseline] version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening. - The study participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN). - The study participant has bilirubin >1.0xULN (isolated bilirubin >1.0xULN is acceptable if bilirubin is fractionated and direct bilirubin 450mL) within the last 30 days prior to Screening. Blood donation during the study is not permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics 1. Maximum plasma concentration (Cmax) of a single dose padsevonil [ Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) ] Cmax: Maximum observed plasma concentration 2. Area under the curve from 0 to t (AUC0-t) of a single dose padsevonil [ Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) ] AUC0-t: Area under the plasma concentration-time curve from time zero to time t 3. Area under the curve from time 0 to infinity of a single dose padsevonil [ Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) ] AUC: Area under the plasma concentration time curve from zero up to infinity 4. Terminal half-life (t1/2) of a single dose padsevonil [ Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) ] t1/2: Apparent terminal half-life 5. Time to reach the maximum plasma concentration (tmax) of a single dose padsevonil [ Time Frame: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) ] tmax: Time of observed maximum plasma concentration 6. Maximum plasma concentration (Cmax) of padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ] Cmax: Maximum observed plasma concentration 7. Area under the curve over a dosing interval (AUCtau) for padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ] AUCtau: Area under the plasma concentration time curve over a dosing interval 8. Terminal half-life (t1/2) of padsevonil at steady-state [ Time Frame: Day 10: Predose and 0 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours postdose (up to day 13) ] t1/2: Apparent terminal | — |
Secondary
| Measure | Time frame |
|---|---|
| other - | — |
Countries
Japan
Outcome results
None listed