Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers
Condition: Healthy Volunteer Study
Intervention: ODM-106; Placebo
Intervention description: Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.; Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained.

          -  Participants must be able to speak, read and understand German.

          -  Good general health ascertained by detailed medical history and physical examinations.

          -  Males 18-45 years (inclusive).

          -  Body mass index (BMI) 18-30 kg/m2 inclusive

          -  Weight 55-95 kg (inclusive).

          -  Participants with female partners of child-bearing potential must adhere to a proper
             form of contraception from first study treatment administration until 3 months after
             the end-of-study visit.

        Exclusion Criteria:

          -  A predictable poor compliance or inability to understand and comply with protocol
             requirements, instructions and protocol-stated restrictions or communicate well with
             the investigator.

          -  Vulnerable subjects.

          -  Veins unsuitable for repeated venipuncture.

          -  Evidence of clinically relevant cardiovascular, renal, hepatic, haematological,
             gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or
             psychiatric disease as judged by the investigator. The participants should be healthy
             subjects.

          -  Subjects with a medical history of relevant psychiatric disorders or evidence of
             significant neuropsychiatric disease

          -  Any condition requiring regular concomitant medication including herbal products or
             likely to need any concomitant medication during the study.

          -  Definite or suspected personal history of hypersensitivity to drugs or excipients.

          -  Intake of any medication that could affect the outcome of the study, as judged by the
             investigator, within 2 weeks before first study treatment administration (2 months for
             enzyme inducing drugs like rifampicin or carbamazepin), or less than 5 times the
             half-life of the medication.

          -  A history of alcoholism or excess alcohol intake (including regular consumption of
             more than 21 units of alcohol per week) .

          -  Use of nicotine-containing products within 6 months of admission and inability to
             refrain from using nicotine-containing products during the study.

          -  History of drug abuse or positive drug screen for amphetamine, barbiturates,
             benzodiazepines, cannabinoids, cocaine, opiates, methamphetamine or methadone.

          -  Propensity to get headache when refraining from caffeine-containing beverages.

          -  Blood donation or loss of clinically relevant amount of blood within 2 months before
             the screening visit.

          -  Abnormal 12-lead ECG finding of clinical relevance at the screening visit

          -  Heart rate (HR) < 50 bpm or > 90 bpm after 10 min in rest (supine) at the screening
             visit

          -  At the screening visit: systolic BP < 90 mmHg or > 140 mmHg, diastolic BP < 50 mmHg or
             > 90 mmHg, orthostatic hypotension decrease of greater than or equal to 20 mmHg for
             systolic BP, decrease of greater than or equal to 10 mmHg for diastolic BP.

          -  Abnormal 24-h Holter of clinical relevance at the screening visit,

          -  Positive serology to human immunodeficiency virus (HIV) antibodies, hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.

          -  Any abnormal value of laboratory, vital signs, or physical examination, which may in
             the opinion of the investigator interfere with the interpretation of the test results
             or cause a health risk for the subject if he takes part in the study.

          -  Participation in an investigational drug study within 2 months before entry into this
             study.

          -  An employee, a direct or indirect relative of the employee of the contract research
             organisation or the sponsor.

          -  Any other condition that in the opinion of the investigator would interfere with the
             evaluation of the results or constitute a health risk for the subject.

          -  Subject with abnormal standard EEG judged as clinically relevant by the investigator
             at screening.