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The principal aim of this study is to obtain safety and tolerability data when PXT002331 is administered orally as single and multiple doses to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PXT002331 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PXT002331 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events | 16 days | |
| Number of clinically relevant signs or symptoms | 16 days |
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Inclusion Criteria:
Subjects will be; 1.1. males or females of non childbearing potential 1.2. For females, non childbearing potential is defined as follows:
Subjects will have a 2.1. body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive 2.2. body weight between 50 kg and 100 kg, inclusive
Subjects will be in good health, as determined by; 3.1. medical history 3.2. physical examination 3.3. vital signs assessment 3.4. 12 lead ECG and 24 hour Holter Monitoring 3.5. clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is not acceptable)
Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Kingdom | United Kingdom | United Kingdom |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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