Parkinsonism Parkinson's Disease
Conditions
Interventions
None listed
Sponsors
Arvinas Operations, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 18 - 70 years of age at screening (inclusive). 2. BMI in the range of 18 - 30 kg/m2, inclusive at screening and with a minimum weight of 50 kg. 3. Able to speak, read, and understand study procedures in Dutch sufficiently to allow completion of all study assessments. 4. Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures. 5. Women of childbearing potential must use a form of birth control (e.g., oral contraceptive, condom use, IUD, abstinence of heterosexual intercourse) during the study.
Exclusion criteria
Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the participant in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance. 5. Abnormal findings in the resting ECG at screening defined as: - QTcF longer than 450 or shorter than 350 msec for men and QTcF longer then 470 or shorter then 360 msec for women - Notable resting bradycardia (HR under 40 bpm) or tachycardia (HR over 100 bpm) - Other abnormal findings in the resting ECG as determined by the investigator 8. Use of any medications (prescription or over-the-counter [OTC] including herbal medication), within 14 days prior to the first blood collection on day 1, or less than 5 half-lives (whichever is longer), except for birth control, paracetamol (up to 4 g/day), and ibuprofen (up to 1g/day). Other exceptions will only be made if the rationale is clearly documented by the investigator. 18. For CSF sampling, any of the criteria below: - History of clinically significant hypersensitivity to local anaesthetics that may be used for LP (e.g., lidocaine). - Criteria that would preclude an LP, such as a local infection at the site of the LP, less then 100x 103/µl platelet count at screening or clinically significant coagulation abnormality or significant active bleeding, or treatment with an anticoagulant or treatment with more than 2 antiplatelet agents. - History of clinically significant back pathology and/or back injury (e.g., degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoints include total LRRK2 protein, pS935 LRRK2 protein, and pRab10/Rab10 levels measured in PBMCs. | — |
Secondary
| Measure | Time frame |
|---|---|
| • LRRK2 protein in CSF | — |
Countries
Netherlands
Outcome results
None listed