Patient Resources for Risvodetinib (IkT-148009)
Risvodetinib (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.
Completed
Risvodetinib (IkT-148009)-101 ("the 101 Trial")
This Phase 1/1b study investigates the safety and tolerability of the drug Risvodetinib (IkT-148009) in healthy elderly volunteers (55 to 70 years old) and in Parkinson’s patients. It also looks at the pharmacology of Risvodetinib (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 Risvodetinib (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 Risvodetinib (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 Risvodetinib (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
Risvodetinib (IkT-148009)-201 (“the 201 Trial”) in Parkinson’s disease
This Phase 2 study investigates the safety and tolerability of the c-Abl inhibitor Risvodetinib (IkT-148009) at three doses in 120 untreated Parkinson’s patients (Hoehn & Yahr < 3.0, ages 30 to 80 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, evaluatessleep and evaluates swallowing, digestion and defecation. Exploratory endpoints include evaluation of disease pathology in skin, spinal fluid and GI tract. Up to forty sites in the U.S. will participate in this study.
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Planned
Risvodetinib (IkT-148009)-202 (“the 202 Trial”) in Multiple Systems Atrophy
This Phase 2a study investigates the safety and tolerability of the drug Risvodetinib (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.
Active
IkT-001Pro-501 (“the 501 Trial”) in Chronic Myelogenous Leukemia
This bioequivalence study will evaluate four doses of IkT-001Pro, the prodrug of imatinib mesylate, in two parts. Part A will evaluate four 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. Part C is planned to measure bioequivalence at steady-state for 600 mg imatinib. One site in the U.S. is planned for this study.
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