ongitudinal Study to Evaluate Intra- and Inter-Individual Variability of LRRK2 Protein and Related Biomarkers in Healthy Participants

Completed

• Conditions: Parkinsonism; Parkinson's Disease; 10028037

• Registration Number: NL-OMON53216
• Lead Sponsor: Arvinas Operations, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The endpoints include total LRRK2 protein, pS935 LRRK2 protein, and<br /><br>pRab10/Rab10 levels measured in PBMCs.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• LRRK2 protein in CSF</p><br>