A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

Exclusion Criteria

• •1. Diagnosis/suspicion of secondary or atypical parkinsonism
• •2. Previous procedure or surgery for PD, or anticipation of these during the study
• •3. High likelihood of needing anti-parkinsonian treatment over the study period, in the opinion of the investigator
• •4. Clinically significant orthostatic hypotension
• •5. Clinically significant hallucinations requiring antipsychotic use in the 12 months prior to Screening
• •6. Clinically significant medical, surgical, psychiatric, or laboratory abnormalities in the judgement of the treating investigator or the EAC
• •Prior/Concomitant Therapy:
• •1. Past treatment with levodopa, dopaminergic agonists, monoamine oxidase-B inhibitors, supplements containing levodopa (i.e. Mucana pruriens), or A2A antagonists for more than 28 days, or treatment with any of these medications or supplements within 28 days prior to screening
• •2. Past treatment with irreversible monoamine oxidase-B inhibitors (e.g., selegiline) for more than 28 days; must be discontinued for at least 90 days before screening
• •3. Currently receiving moderate or strong Cytochrome P450 (CYP) 3A4/5 inducers or CYP3A4/5 inhibitors (except for topical administration)
• •4. Currently receiving any antipsychotic, metoclopramide, reserpine, or amphetamine.
• •Prior/Concurrent Clinical Study Experience:
• •1. Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening
• •2. Previous randomization into this or another IkT-148009 study
• •Diagnostic Assessments:
• •1. Active suicidal ideation within one year prior to screening visit, as determined by the Columbia Suicide Rating Scale (answer of "yes" on question 4 or 5)
• •2. Current diagnosis or history of substance abuse (excluding nicotine or caffeine) by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
• •3. Medical or recreational use of marijuana in the 3 months prior to the screening visit
• •4. Any social or behavioral reason that would preclude completion of the study, in the judgement of the investigator
• •5. Any skin condition that would interfere with obtaining adequate samples
• •6. Evidence of advanced, age-related macular degeneration (neovascular or geographic atrophy) or intermediate macular degeneration as defined by Beckman classification (Large drusen \> 125 um and/or any AMD pigmentary abnormalities). Evidence of retina/choroid neovascularization from any cause. Evidence of central serous retinopathy.
• •7. Abnormal amylase and/or lipase at screening (may be repeated during screening period)
• •8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN)
• •9. Significant renal impairment as determined by the following criteria:
• •* Creatinine clearance (CrCL) less than or equal to 60 mL/min for subjects \< 65 years of age
• •* Creatine clearance (CrCL) greater than or equal to 55 mL/min and the absence of proteinuria or hematuria for subjects ≥ 65 years of age
• •10. Currently lactating, pregnant or planning on becoming pregnant during the study