Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Placebo
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson's disease (PD); Opicapone; Bial; BIA 9-1067

Summary:

      The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising
      dose regimens of BIA 9-1067.
    

Eligibility criteria:

        Inclusion Criteria:

          1. A signed and dated informed consent form before any study-specific screening procedure
             is performed.

          2. Aged between 18 and 45 years, inclusive.

          3. Healthy as determined by the investigator on the basis of medical history, physical
             examination, clinical laboratory test results, vital signs and digital 12-lead
             electrocardiogram (ECG).

          4. Nonsmoker 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:

          1. 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.

          2. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before
             study day 1.

          3. History of drug abuse within 1 year before study day 1.

          4. 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

          5. Have previously received BIA 9-1067.

          6. Positive serologic findings for human immunodeficiency virus (HIV) antibodies,
             hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

          7. Positive findings of urine drug screen (eg, amphetamines, barbiturates,
             benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA
             [3,4-methylenedioxy-methamphetamine; ecstasy]).

          8. History of any clinically important drug allergy.

          9. Prohibited Treatments: use of any investigational drug within 90 days or prescription
             drug within 30 days before investigational medical product (IMP) administration.

         10. 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 before study day 1.

         11. 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.

         12. Donation of blood (ie 450 ml) within 90 days before study day 1.