Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
Condition: Parkinson
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067
Intervention description: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opicapone,; Parkinson,; Bial,; BIA 9-1067

Summary:

      The objectives of this study were to characterize the effects of food on the pharmacokinetics
      (PK) and tolerability of BIA 9-1067 in healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability for the entire study period and willingness to adhere to the protocol
             requirements as evidenced by the informed consent form (ICF) duly read, signed and
             dated by the volunteer

          -  Male volunteer

          -  Volunteer aged of at least 18 years but not older than 45 years

          -  Volunteer with a body mass index (BMI) greater than or equal to 18.5 and below 30
             kg/m2

          -  Clinical laboratory values within the laboratory's stated normal range; if not within
             this range, they must be without any clinical significance

          -  Healthy according to the medical history, laboratory results and physical examination

          -  Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes
             or less per day for at least 3 months before day 1 of this study. An ex-smoker is
             defined as someone who completely stopped smoking for at least 12 months before day 1
             of this study

          -  The informed consent form must be signed by all volunteers, prior to their
             participation in the study.

        Exclusion Criteria:

          -  Volunteers presenting any of the following will not be included in the
             study:Significant history of hypersensitivity to any catechol-structured drugs (e.g.
             rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or
             dobutamide) or any related products (including excipients of the formulations) as well
             as severe hypersensitivity reactions (like angioedema) to any drugs

          -  Presence of significant gastrointestinal, liver or kidney disease, or any other
             conditions known to interfere with the absorption, distribution, metabolism or
             excretion of drugs or known to potentiate or predispose to undesired effects

          -  History of significant gastrointestinal, liver or kidney disease that may affect drug
             bioavailability

          -  Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic,
             psychiatric, endocrine, immunologic, dermatologic or connective tissue disease

          -  Suicidal tendency, history of or disposition to seizures, state of confusion,
             clinically relevant psychiatric diseases

          -  Presence of significant heart disease or disorder according to ECG

          -  Previous history of Neuroleptic Malignant Syndrome (NMS) and/or nontraumatic
             rhabdomyolysis

          -  Pheochromocytoma due to the increased risk of hypertensive crisis

          -  Use of MAO inhibitors within 14 days of day 1 of the study

          -  Maintenance therapy with any drug, or significant history of drug dependency or
             alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or
             chronic)

          -  Any clinically significant illness in the previous 28 days before day 1 of this study

          -  Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450
             (CYP) enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin,
             fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP
             enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin and
             rifampin), in the previous 28 days before day 1 of this study

          -  Volunteers who took an Investigational Product (in another clinical trial) or donated
             50 mL or more of blood in the previous 28 days before day 1 of this study

          -  Poor motivation, intellectual problems likely to limit the validity of consent to
             participate in the study or limit the ability to comply with the protocol requirements
             or inability to cooperate adequately, inability to understand and to observe the
             instructions of the physician

          -  Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical
             studies, etc.) in the previous 56 days before day 1 of this study

          -  Positive urine screening of drugs of abuse

          -  Any history of tuberculosis and/or prophylaxis for tuberculosis

          -  Positive results to HIV, HBsAg or anti-HCV tests