A Study of Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

Exclusion Criteria

• •Participant has clinically significant unstable medical conditions other than epilepsy.
• •Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
• •Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), greater than:
• •* 450 msec for males.
• •* 470 msec for females.
• •* 480 msec if right bundle branch block is present.
• •Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
• •Participant has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or enrollment, other than epilepsy.
• •Participant is currently using felbamate and has been taking it for less than 12 months prior to screening.
• •Participant has consumed alcohol during the 7 days prior to enrollment and is unwilling to abstain during the blinded phase of the trail.
• •Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry.
• •Participant has any known or suspected history of any drug abuse or addiction.
• •Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) for the duration for the study.
• •Participant has consumed grapefruit or grapefruit juice 7 days prior to enrollment and is unwilling to abstain from drinking grapefruit juice within 7 days of pharmacokinetic visits.
• •Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.
• •Participant has received an IMP within the 12 weeks prior to the screening visit.
• •Participant has significantly impaired hepatic function at the screening or randomization visit, defined as any of the following:
• •* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 × upper limit of normal (ULN).
• •* ALT or AST \> 3 × ULN and total bilirubin (TBL) \> 2 × ULN or international normalized ratio (INR) \> 1.5.
• •* ALT or AST \> 3 × ULN with the presence of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (\> 5%).