Healthy Volunteer Study Clinical Trial
Official title:
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Escalating Doses of ODM-106: A Randomised, Double-blind, Placebo-controlled Single Centre Study in Healthy Males
The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.
Eight planned dose levels of ODM-106 will be compared with placebo.There will be 2 panels of
subjects with 4 dose levels in each panel. Subjects will be randomised to receive 3 dose
levels of active treatment (single doses) and 1 dose of placebo. The dose levels will be
escalated from the smallest dose upwards within the study and within the study subject. A
third panel of 8 subjects may be included to investigate further dose levels of ODM-106,
investigate the effect of taking ODM-106 with food or to compare two different formulations
of ODM-106. For an individual subject, the study will consist of a screening period (maximum
4 weeks), 4 study treatment periods with a wash-out period between each study treatment
administration and a post-treatment period of about 2 weeks.
The study duration for an individual will be approximately 12-16 weeks. Blood samples will
be collected for the assessment of the concentration of ODM-106 and its metabolite.Plasma
samples and cumulative urinary samples will be collected for metabolite screening. Safety
will be assessed by a 12-lead electrocardiogram (ECG), continuous ECG monitoring, Holter
ECG, supine and orthostatic blood pressure and heart rate, body temperature, physical
examination, electroencephalogram (EEG), laboratory safety assessments and adverse events.
Sedation and psychomotor tests and a quantitative EEG will also be performed.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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