A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Placebo
Intervention description: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects; single-dose
Intervention MeSH terms: Opicapone; Entacapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BIA 9-1067

Summary:

      The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and
      catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after
      single oral ascending doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A signed and dated informed consent form before any study-specific screening procedure
             was performed.

          -  Aged between 18 and 45 years, inclusive.

          -  Healthy as determined by the investigator on the basis of medical history, physical
             examination, clinical laboratory test results, vital signs and digital 12-lead ECG.

          -  Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history.
             Must be able to abstain from smoking during the inpatient stay.

        Exclusion Criteria:

          -  Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g.
             childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia),
             immunologic, dermatological, haematological, neurologic, or psychiatric disease.

          -  Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before
             study day 1.

          -  History of drug abuse within 1 year before study day 1.

          -  History of alcoholism within 1 year before day 1. Consumption of more than 50 g of
             ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%]
             whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15
             g

          -  Positive serologic findings for human immunodeficiency virus (HIV) antibodies,
             hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

          -  Positive findings of urine drug screen (eg, amphetamines, barbiturates,
             benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA
             [3,4-methylenedioxy-methamphetamine; ecstasy]).

          -  History of any clinically important drug allergy.

          -  Prohibited Treatments: use of any investigational drug within 90 days or prescription
             drug within 30 days before investigational medical product (IMP) administration.

          -  Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or
             soda) in excess of 6 cups per day (or equivalent), of grapefruit,
             grapefruit-containing products, or alcoholic beverages within 24 hours before study
             day 1.

          -  Use of any over-the-counter drugs including herbal supplements (except for the
             occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended
             daily allowance) within 7 days before IMP administration.

          -  Donation of blood (i.e. 450 mL) within 60 days before study day 1