Epilepsy seizures
Conditions
Interventions
Padsevonil, placebo of padsevonil ethanol, placebo of ethanol, cannabidiol
Sponsors
UCB Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. - Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. - Participant must have previous experience with alcohol consumption and, therefore, must be familiar with the effects and able to tolerate social amounts of alcohol. - Participant has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18 to 30 kg/m2 (inclusive) - Participants are male or female: A male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: +Not a woman of childbearing potential (WOCBP) as defined n the protocol OR +A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 90 days after the last dose of study treatment. -Participant must be capable of giving signed informed consent as described in Appendix 1 (Section 10.1), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). - Participant must be considered reliable and capable of adhering to the protocol, according to the judgment of the Investigator, and is capable of communicating satisfactorily with the Investigator.
Exclusion criteria
Exclusion criteria: -Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant*s 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. - Participant has 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 - Participant has a history of chronic alcohol or drug abuse within the previous 6 months or the presence of drug or alcohol dependency at Screening or Day -1 or tests positive for alcohol and/or drugs at Screening or Day -1 -Participant has a positive prestudy drug screen (to include at minimum: amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines). - Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol -Participant has abnormal blood pressure. -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 C-SSRS at Screening. - Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome - Participant has lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years - Participant has past or intended use of over-the-counter or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing. Specific mediactions listed in section 6.5.1. may be allowed. - Participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin etc.) within 2 months prior to dosing. In case of uncertainty, the Medical Monitor should be consulted. - Participant has previously received PSL in this or any other study. - Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days of Screening or 5 half-lives whichever is longer or is currently participating in another study of an IMP (and/or an investigational device). - Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.0x upper limit of normal (ULN) - Participant has bilirubin >1.0xULN (isolated bilirubin >1.0xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). - Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) - Participant has any clinically
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of smooth pursuit eye movements during Part A 2. Cmax for padsevonil during part B 3. Cmax for cannabidiol during Part B 4. AUC0-tau for padsevonil during Part B 5. AUC0-tau for cannabidiol during Part Bart B | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Ethanol dose infused over time during Part A 2. Cmax for padsevonil during Part A 3. AUC0-tau for padsevonil during Part A 4. T1/2 for padsevonil during Part B 5. T1/2 for cannabidiol during Part B 6. CLss/F for padsevonil during Part B 7. CLss/F for cannabidiol during Part B 8. Saccadic peak velocity to assess sedation during Part A 9. Saccadic peak velocity to assess sedation during Part B 10. Adaptive tracking to assess visuo-motor control and vigilance during Part A 11. Adaptive tracking to assess visuo-motor control and vigilance during Part B 12 Smooth pursuit (%) to assess eye movement coordination and attention for Part B only 13. Body sway to assess postural stability during Part A 14. Body sway to assess postural stability during Part B 15. Number of participants with Adverse events during Part A 16. Number of participants with Adverse events during Part B 17. Number of participants with Serious Adverse events during Part A 18. Number of participants with Serious Adverse events during Part B 19. Number of participants with Treatment-related Adverse events during Part A 20. Number of participants with Treatment-related Adverse events during Part B 21. Number of participants with Adverse events leading to discontinuation of the study during Part A 22. Number of participants with Adverse events leading to discontinuation of the study during Part B | — |
Countries
Netherlands
Outcome results
None listed