Healthy Clinical Trial
Official title:
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
Verified date | July 2020 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 6 |
Est. completion date | May 30, 2020 |
Est. primary completion date | May 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Biotrial Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Latency of movement from cue measured by accelerometer | Latency of movement from cue (in ms) | From baseline to Day 7 in each Treatment Period | |
Primary | 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 | |
Primary | 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 | |
Primary | Power in the frequency domain of the greater tremor frequency | Power in micro-volts squared | From baseline to Day 7 in each Treatment Period |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |