A Phase 1, Open-Label, Multiple Dose Study to Assess the Pharmacokinetics, Safety, Tolerability, and Food Effect of MRX1 in Healthy Adults

Exclusion criteria

• Female participant who is pregnant or breastfeeding, or planning to become pregnant or breastfeed, or planning to donate ova during study participation.
• History or presence of a medical condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or lead to increased risk of harm.
• Presence of any chronic medical condition requiring ongoing treatment.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to Screening, as per Investigator judgement.
• Documented evidence of current or past cardiovascular disease including cardiac arrhythmias or family history of congenital long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death.
• Any gastrointestinal surgery or condition or disease that could affect drug absorption, distribution, or excretion (e.g., gastrectomy, cholecystectomy, diarrhea, recurrent nausea/vomiting).
• History of malignancy of any organ system (other than localised basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years before Screening, regardless of if there is no evidence of local recurrence or metastases.
• History of schizophrenia, bipolar disorder psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis including generalised anxiety and obsessive-compulsive disorders. Hospitalisation within 5 years before Screening due to psychiatric illness or due to danger to self or others.
• Current use (or within the 3 months prior to Screening) of other cannabinoid or cannabis products.
• History of allergy or other adverse reaction to cannabinoid or cannabis products at any time in the past or known or suspected hypersensitivity to any of the components of the formulation.
• Current or recent (within 2 months prior to Screening) use of any tobacco or nicotine products (including e-cigarettes, vaping, or dipping) at \>5 cigarettes per week or equivalent. Causal/social smokers (≤5 cigarettes per week or equivalent) are permitted.
• History of substance abuse disorder(s), as determined by the Investigator, within 5 years of Screening, including but not limited to alcohol, illicit drugs, and inappropriate use of prescription drugs.
• Positive urine drug test or alcohol breath test at Screening or Day 1, unless there is an explanation deemed acceptable by the Investigator and/or the participant tests negative upon re-test (one re-test permitted per scheduled time point).
• Use of any prescription medicines or marijuana within 14 days of Day -1 or use of any nonprescription medicines, supplements, or vaccines within 7 days of Day 1. Occasional (PRN) paracetamol (up to 2 g/day) or ibuprofen (up to 1.2 g/day) use may be permitted, at Investigator discretion. Hormonal contraceptives are permitted.
• Consumption of food and/or beverages containing Seville oranges or Seville orange juice, or grapefruit or grapefruit juice, or poppy seeds within 7 days prior to Day -1.
• Consumption of caffeine/xanthine products within 24 hours prior to Day -1.
• Use of any investigational drug within 30 days or \<5 half-lives, whichever is longer, prior to first dose of study drug.
• Donation or receipt of any blood or blood products at a blood bank or donation centre within 30 days prior to Screening.
• Identified as a site employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife or de facto and their children, adopted or natural) of the site employees or the Investigator.