A clinical study to compare the safety and tolerability of two formulations of a new drug in Healthy Participants for Parkinson's disease.

Exclusion Criteria34

• A participant will be excluded from the study if they meet any of the following criteria:
• Participant has a suspected hypersensitivity to GT-02287 or excipients.
• Participant has aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), ?-glutamyl transferase (GGT) or total bilirubin superior to 1.5 × ULN at Screening. If a participant is initially excluded due to this criterion, the assessment may be repeated once at the investigator’s discretion prior to Day -1.
• Participant has any clinically significant history of allergies (including drug allergies, allergic eczema, or anaphylactic reactions, but excluding untreated allergic rhinitis or rhinoconjunctivitis caused by seasonal or house dust mite allergy).
• Participant has a history of suicidal behavior or suicide attempts (an answer of “yes” to any lifetime suicidal behaviors on the C-SSRS), has had any active suicidal ideation within the last 3 months before Screening (an answer of “yes” to categories 4 or 5 of the C-SSRS), or who is at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at Screening.
• Participant has or had an active febrile illness or a symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 2 weeks before Day -1.
• Participant has any clinically significant abnormality following the investigator’s review of the physical examination, ECG, vital signs, or clinical laboratory tests at Screening or on Day -1. If a participant is initially excluded due to this criterion, the assessment may be repeated once at the investigator’s discretion prior to Day -1.
• Participant has the below mean heart rate, systolic blood pressure (SBP), or diastolic blood pressure (DBP) when measured at rest in triplicate at Screening or Day -1:
• Mean heart rate inferior to 40 or superior to 100 beats per minute.
• Mean SBP superior to 160 mmHg.
• Mean DBP superior 95 mmHg.
• If the mean pulse, mean SBP, or mean DBP is out of the range specified above, 1 additional triplicate measurement may be taken at Screening or Day -1. If this triplicate also gives an abnormal result, the participant should be excluded.
• Participant has a mean QT interval corrected using Fridericia’s Formula (QTcF) of superior to 450 msec (for males) and superior to 470 msec (for females) at Screening or Day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG can be taken. If this triplicate also gives an abnormal result, the participant should be excluded.
• Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease, or a family history of long QT syndrome.
• Participant has a history of seizures, head trauma, or loss of consciousness.
• Participant uses any prescribed or nonprescribed drugs (including hormone replacement therapy, natural and herbal remedies, e.g., St. John’s Wort) within 2 weeks or 5 half-lives (whichever is longer) before Day -1. Vitamins and dietary supplements are prohibited within 7 days prior to Day -1. Paracetamol at doses up to 2 g/day and hormonal birth control/contraception are allowed.
• Participant has used cigarettes (or equivalent nicotine-containing product) within 4 weeks prior to Screening or has a positive urine cotinine test at Screening or on Day -1. If a participant is initially excluded due to this criterion, the assessment may be repeated once at the investigator’s discretion prior to Day -1.
• Participant has a history of consuming more than 14 units of alcoholic beverages per week (note: 1 unit = 250 mL of beer, 100 mL of wine, or 30 mL of spirits/hard liquor) within 6 months prior to Screening, has a history of alcoholism within 2 years prior to Screening, or has a positive alcohol breath test at Screening or Day -1. If a participant has a positive
• alcohol breath test at Screening, the assessment may be repeated once at the investigator’s discretion prior to Day -1. A positive test on Day 1 is exclusionary.
• Participant has excessive caffeine consumption (defined as superior to 4 cups per day of caffeinated coffee, tea, soda, energy drinks and/or other beverages containing caffeine, or equivalent in chocolate, supplements, or other sources of caffeine) within 2 weeks prior to Day -1.
• Participant is unable to refrain from consumption of grapefruit, grapefruit juice, Seville oranges, pomegranate, tangelo, star fruit, or pomelo fruit within 7 days prior to Day -1 and for the duration of the study.
• Participant has used amphetamines, barbiturates, benzodiazepine, methamphetamine, phencyclidine, methadone, tricyclic antidepressants, cannabinoids, cocaine, or opiates (drugs of abuse) within 3 months before Day -1 or has a positive urine drug screen at Screening or Day -1. If a participant has a positive urine drug screen at Screening, the assessment may be repeated once at the investigator’s discretion prior to Day -1.
• Participant has used medications known to interfere with the CYP3A4 and/or P-gp metabolic pathways during the 3 months prior to Day -1.
• Participant has used dietary supplements or herbal remedies known to interfere with the CYP3A4 and/or P-gp metabolic pathways during the 4 weeks prior to Day -1.
• Participant has had any significant blood loss (superior or equal to 450 mL), donated 1 unit (superior or equal to 450 mL) of blood, or received a transfusion of any blood or blood products within 60 days before Day -1, or has donated plasma within 7 days before Day -1.
• Participant has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus 1 and 2 antibodies (anti- HIV-1, anti-HIV-2).
• Participant has a history of malabsorption, inflammatory bowel disease, pancreatitis, irritable bowel disease, cholecystectomy, Gilbert’s Syndrome, or any other clinically relevant disorder which may impact the absorption, metabolism, or elimination of
• GT-02287.
• Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy, as judged by the investigator or designee. A history of childhood asthma that is resolved (in the opinion of the investigator) is not exclusionary.
• Participant has current or recent history (within the past 6 months) of recurrent headache (e.g., tension-type, cluster, or migraine with a frequency of superior or equal to 2 episodes per month and requiring treatment), which, in the opinion of the investigator, precludes participation in the study.
• Participant has a history of severe depression, or mild/moderate depression lasting more than or equal to 3 months, requiring hospitalization and/or pharmacological therapy, or recent history (within the past 6 months of any other psychiatric condition which, in the opinion of the investigator, precludes participation in the study.
• Participant’s estimated glomerular filtration rate (eGFR) (calculated based on the modified Cockcroft-Gault formula) is inferior to 60 mL/min/1.73 m2.
• Participant has participated in any interventional clinical study or has been treated with any investigational drugs (including GT-02287) within 1 month or 5 half-lives, whichever is longer, before Screening. Previous participation in a GT-02287 clinical study prior to this period is not exclusionary.
• Participant is an employee of the Gain Therapeutics group, or any vendor involved in the study.