Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate effects of foliglurax on brain wave patterns (electric signals) in healthy subjects and in patients with PD

Detailed Description
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All Treatment Periods (P1 to P3) consist of 7 days of dosing (D1 to D7) with either: 10 mg foliglurax bis in die (BID) (treatment A) 30 mg foliglurax BID (treatment B) Placebo BID (treatment C)

Official Title
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Interventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy Subjects

Conditions
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Parkinson Disease, Healthy

Intervention / Treatment
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* Drug: Foliglurax 10 mg (treatment A)
* Drug: Foliglurax 30 mg (treatment B)
* Drug: Placebo (treatment C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects The subject has an acceptable resting EEG at the Screening Visit, as judged by the investigator The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. Patients with PD The patient has an acceptable resting EEG performed at the screening period, as judged by the investigator. The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. The patient has been diagnosed with idiopathic PD for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the 'off' state. The patient has dyskinesia that is not too severe to cause discomfort for the patient during the EEG assessments Exclusion criteria: The subject has taken disallowed medication <1 week prior to the first dose of Investigational Medicinal Product (IMP) or <5 half-lives prior to the Screening Visit for any medication taken. The subject has significant alcohol consumption The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP. The subjects has a known genetic disorder of human UDPglucoronosyltransferase The subject is pregnant or breastfeeding. Other in- and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy<br> | Drug: Foliglurax 10 mg (treatment A)<br>* Foliglurax 10 mg, (BID) capsules, orally<br>Drug: Foliglurax 30 mg (treatment B)<br>* Foliglurax 30 mg, BID capsules, orally<br>Drug: Placebo (treatment C)<br>* Placebo, BID capsules, orally<br>|
| Experimental: PD<br> | Drug: Foliglurax 10 mg (treatment A)<br>* Foliglurax 10 mg, (BID) capsules, orally<br>Drug: Foliglurax 30 mg (treatment B)<br>* Foliglurax 30 mg, BID capsules, orally<br>Drug: Placebo (treatment C)<br>* Placebo, BID capsules, orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency of EEG movement related desynchronization of the μ-oscillations | Latency of μ-desynchronization ipsilateral and contralateral (in ms) | From baseline to Day 7 in each Treatment Period | 
| Latency of EEG movement related synchronization of the beta-oscillations | Latency of beta-rebound ipsilateral and contralateral (in ms) | From baseline to Day 7 in each Treatment Period | 
| Offset of EEG movement related synchronization of the beta-oscillations | Offset of beta-rebound ipsilateral and contralateral (in ms) | From baseline to Day 7 in each Treatment Period | 
| Latency of movement from cue measured by accelerometer | Latency of movement from cue (in ms) | From baseline to Day 7 in each Treatment Period | 
| Average power in u-desynchronization cluster measured by EEG | Power in μ-desynchronization cluster ipsilateral and contralateral (in micro-volts squared) | From baseline to Day 7 in each Treatment Period | 
| Average power in beta-rebound cluster measured by EEG | Power in beta-rebound cluster ipsilateral and contralateral (in micro-volts squared) | From baseline to Day 7 in each Treatment Period | 
| Power in the frequency domain of the greater tremor frequency | Power in micro-volts squared | From baseline to Day 7 in each Treatment Period |