Patient Resources

Patient Resources for IkT-148009

IkT-148009 is a potent small-molecule medication designed and engineered as a chronically administered oral medication that targets the underlying biological mechanism that leads to Parkinson’s disease. The goal of the medication is to halt and reverse the loss of function for dopamine-secreting neurons in the brain and GI tract.

Active

IkT-148009-101 ("the 101 Trial")

This Phase 1/1b study investigates the safety and tolerability of the drug IkT-148009 in healthy elderly volunteers (55 to 70 years old) and in Parkinson’s patients. It also looks at the pharmacology of IkT-148009 in the body. This first-in-human study is designed in 3 parts. In Part A, healthy participants will take a single, oral dose of IkT-148009 or placebo. Part A participants will be at the study site for approximately 4 days. In Part B, healthy participants will take an oral dose of IkT-148009 once a day for 7 days. Part B participants will be at the study site for approximately 12 days. In Part C, Parkinson’s patients will take an oral dose of IkT-148009 once a day for 7 days. Part C participants will be at the study site for approximately 12 days.

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Active

IkT-148009-201 (“the 201 Trial”) in Parkinson’s disease

This Phase 2a study investigates the safety and tolerability of the drug IkT-148009 at three doses in 120 untreated, early stage Parkinson’s patients (Hoehn & Yahr < 2.0, ages 45 to 75 years old) who do not currently take any medications to control their disease. Primary endpoints are safety and tolerability, as this study represents the first long-term dosing study. Secondary endpoints evaluate a hierarchy of motor and non-motor features in the central nervous system, evaluate sleep and evaluate swallowing, digestion and defecation. Exploratory endpoints include evaluation of disease pathology in skin, spinal fluid and GI tract. Forty sites in the U.S. will participate in this study.

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Planned

IkT-148009-202 (“the 202 Trial”) in Multiple Systems Atrophy

This Phase 2a study investigates the safety and tolerability of the drug IkT-148009 at two doses in patients with Multiple Systems Atrophy (MSA). Primary endpoints are safety and tolerability, as this study represents the first long-term dosing study in this patient population. Secondary endpoints evaluate a hierarchy of motor and non-motor features in the central nervous system and GI tract. Patients enrolled in this study will be allowed to continue on their current treatment regimen to control symptoms of the disease. Twenty-fives sites in 4 E.U. countries and the U.S. are planned for this study.

Planned

IkT-001Pro-501 (“the 501 Trial”) in Chronic Myelogenous Leukemia

This bioequivalence study will evaluate three doses of IkT-001Pro, the prodrug of imatinib mesylate, in two parts. Part A will evaluate three doses of 001Pro to match the pharmacokinetics of imatinib mesylate 400 mg in healthy volunteers. Part B will confirm the dose in a larger population of healthy volunteers. One site in the U.S. is planned for this study.