Healthy Clinical Trial
Official title:
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single and Multiple Escalating Doses of ODM-108: A Single Centre Study in Healthy Male Volunteers
The purpose of the study is to investigate to what extent this new study drug is tolerated in
humans.
The study is divided into 3 parts (Part III is optional and may go ahead depending on the
results of Parts I and II). The volunteers will only be enrolled to one part of the study. In
parts I and II the volunteer will receive active study drug or placebo. In part I the
volunteers will receive a single dose of one of the eight planned escalating dose levels.
In part II volunteers will receive 4 planned dose levels based on the results obtained in
Part 1 of the study, with the option to include an additional dosing group.
In optional part III the volunteer will receive ODM-108 and an already registered drug so
that interactions with other drugs can be studied.
It will be investigated how quickly and to what extent the study drug is absorbed and
eliminated from the body (this is called pharmacokinetics). In addition, in parts I and II
the effect of the compound on the sensation of pain and on cognition (activities of thinking,
understanding, learning, and remembering) will be investigated (this is called
pharmacodynamics).
This is the first time that this compound is being given to humans.
The study will only take place after it has been approved by the Independent Ethics
Committee.
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