Dose-finding Pharmacokinetic Study in Healthy Males
Condition: Healthy Volunteers
Intervention: Levodopa; Carbidopa; ODM-104
Intervention description: Levodopa 50 mg or 100 mg or 150 mg; Carbidopa 12.5 mg or 25 mg or 65 mg; ODM-104 50 mg or 100 mg
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase I PK study in healthy males.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent (IC) obtained.

          -  Good general health ascertained by detailed medical history and physical examinations.

          -  Males between 18-65 years of age inclusive at screening.

          -  Body mass index (BMI) between 19-30 kg/m2 (BMI = weight/height2) inclusive at
             screening.

          -  Weight at least 55 kg inclusive at screening.

          -  Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or
             other intestinal problems, and no history of major gastrointestinal surgery).

          -  Subject with a partner of childbearing potential agrees to use adequate contraception
             from the first dose of study treatment until 90 days after the last dose of study
             treatment. Adequate methods of contraception include: Hormonal contraceptives, barrier
             methods (condom, diaphragm, cervical cap, etc.) in combination with a spermicide,
             intrauterine device and sexual abstinence.

          -  Subject agrees to not donate sperm from the first dose of study treatment until 90
             days after the last dose of study treatment.

        Exclusion Criteria:

          -  Evidence of clinically significant cardiovascular, renal, hepatic, haematological,
             gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease
             or cancer (except local non-melanoma skin cancer) within the previous 2 years.

          -  Any condition requiring regular concomitant treatment (including vitamins and herbal
             products) or likely to need any concomitant treatment during the study. As an
             exception, paracetamol for occasional pain is allowed.

          -  Any clinically significant abnormal laboratory value or ECG (such as prolonged QTcF
             >450 ms or QRS >120 ms) that in the opinion of the investigator could interfere with
             the interpretation of study results or cause a health risk for the subject if he takes
             part in the study.

          -  Known hypersensitivity to the active substances or the excipients of the drugs.

          -  History of vasovagal collapses or vagal reactions with unexplained reason within the
             previous 2 years or a tendency for vasovagal reactions during blood sampling.

          -  HR < 50 bpm or > 90 bpm in the supine position after 5 min rest at the screening
             visit.

          -  At the screening visit:

               -  systolic BP < 100 mmHg or > 140 mmHg in the supine position after 5 min rest

               -  diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 5 min rest.

          -  Creatinine > 1.5 x upper limit of normal (ULN) and alanine aminotransferase or
             aspartate aminotransferase >1.25 x ULN at screening.

          -  History of anaphylactic/anaphylactoid reactions.

          -  Strong tendency to motion sickness.

          -  Recent or current (suspected) drug abuse.

          -  Recent or current alcohol abuse; regular drinking of more than 21 units per week (1
             unit = 4 cl spirits or equivalent).

          -  Current use of nicotine-containing products more than 5 cigarettes (or equivalent)/day
             and/or inability to refrain from the use of nicotine-containing products for 48 h
             before the first dose in each period until collection of the 24 h PK sample in the
             morning of day 8.

          -  Use of caffeine-containing beverages more than 600 mg of caffeine/day and/or inability
             to refrain from using caffeine-containing beverages 24 h before the first levodopa
             administration on the PK day (day 7) until collection of the 24 h PK sample in the
             morning of day 8.

          -  Blood donation or loss of a significant amount of blood (> 500 ml) within 90 days
             before the first study treatment administration.

          -  Participation in another investigational drug study or administration of another
             investigational drug within 60 days before the first study treatment administration.

          -  Veins unsuitable for repeated venipuncture or cannulation.

          -  Predictable poor compliance or inability to communicate well with the study centre
             personnel.

          -  Inability to participate in all treatment periods.