An interventional study to assess the safety, pharmacokinetic (PK, the measure of how the human body processes a substance) response and tolerability (how well a substance is tolerated by participants) to Zolmitriptan following multiple oral doses in Adult Healthy Volunteers

Exclusion Criteria20

• 1. Have taken, with 4 weeks of Screening or Intake, any of the following:
• Selective Serotonin Reuptake Inhibitors (SSRIs)
• Serotonin-Norepinephrine Reuptake Inhibitor (SNRIs).
• Any MAO-O inhibitor
• Another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication (example: dihydroergotamine or methysergide), including St John’s wort
• Any MAO-A inhibitor
• Are taking cimetidine and are unable to discontinue use of cimetidine from Screening until the End of Study follow-up.
• Significant current use of tobacco products, as judged by the Investigator.
• Have a diagnosis or clinical history of cardiac, cerebrovascular or peripheral vascular disease, including Prinzmetal’s angina and Wolff-Parkinson-White syndrome
• Screening or Intake systolic blood pressure =180mmHg (confirmed with repeat readings), or a clinical history of uncontrolled or severe hypertension.
• Evidence of clinically significant ECG abnormalities at Screening or Baseline, in the clinical judgement of the Investigator.
• Screening or Intake liver function tests that demonstrate an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3X the upper limit of normal.
• Diagnosed with, or clinical history of epilepsy or structural brain lesions reported at screening.
• Known history of alcohol use disorder or other substance use disorder within 6 months prior to Screening.
• Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at screening.
• Pregnant or lactating female subjects.
• History of galactose intolerance (i.e. Lapp lactase deficiency or glucose-galactose malabsorption).
• Participating in any other study and have received any other investigational medication or device within 30 days prior to screening or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study.
• Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk of safety/tolerability issues and/or would preclude obtaining voluntary consent and/or would confound the interpretation of the primary outcome measures in the study.
• Unwillingness or inability to comply with the study protocol, (including abstaining from all tobacco products during the dosing period), for any other reason.