Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease

This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease

Inclusion Criteria: 1. Male and Female from 40 to 80 years old; 2. Diagnosed with "Clinically Probable Parkinson's Disease" according to the MDS clinical diagnostic criteria, with documented onset of symptoms per treating physician's records within three years of the screening visit; 3. Positive DAT-scan (e.g. a striatal dopamine transporter deficit on dopamine transporter imaging by DaT-SPECT, characterized by crescent-shaped areas of asymmetrical aspect, or of symmetrical aspect but of uneven intensity, between the right and the left brain hemisphere) confirmed by local reading; 4. Hoehn \& Yahr stage ≤ 2.5; 5. Without previous symptomatic treatment for PD disease and with current clinical state not requiring started dopaminergic therapy within 6 months from Baseline; 6. Absence of a parkinsonian syndrome and other neurovascular comorbidities, confirmed by MRI 7. Female subjects must be not of childbearing potential, e.g., documented evidence that they are surgically sterile (e.g., hysterectomy, partial hysterectomy, bilateral oophorectomy, bilateral tubal ligation), or postmenopausal (at least 12 months since last menses) or using highly effective method of birth control defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intra uterine devices (IUDs), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, condom, until at least one month after the last drug intake associated to a negative pregnancy test at screening; 8. Covered by Health Insurance System; 9. Able to understand and to sign the informed consent prior to screening; 10. Blood Pressure (BP) and Heart Rate (HR) considered NCS by Investigator; 11. Electrocardiogram (ECG) recording on a 12-lead ECG considered NCS by Investigator; 12. Laboratory parameters within the normal range of the laboratory. Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator. Exclusion Criteria: 1. Atypical Parkinsonism or drug-induced Parkinsonism; 2. Current, or within 60 days of screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. 3. Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine, rasagiline) for 30 or more days any time in the past; 4. Cognitive impairment (MMSE ≤ 24); 5. Active psychiatric disorder (mood disorders, hallucinations or delirium with strong functional impact and not controlled by medication or which happened during the last 3 months before inclusion); 6. Severe or uncontrolled chronic disease; 7. Significant medical history of congenital or acquired bleeding disorders; 8. Treatment by Deep Brain Stimulation or continuous infusion of apomorphin/dopa gel; 9. Any below impaired cardiac function: * LVEF \