Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opicapone; BIAL

Summary:

      The purpose of this study is to determine the effects of age on the pharmacokinetic (PK)
      profile of BIA 9-1067 and its metabolites.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects (young and elderly):

          1. A signed and dated informed consent form before any study-specific screening procedure
             is performed.

          2. 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).

          3. Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Had
             to be able to abstain from smoking during the inpatient stay.

          4. With a body mass index (BMI) between 19 and 30 kg/m2, inclusive.

             Young subjects only:

          5. Males aged between 18 and 40 years, inclusive.

             Elderly subjects only:

          6. Males older than 65 years, inclusive.

        Exclusion Criteria:

        All subjects (young and elderly):

        General

          1. Subjects who had participated in a clinical trial with an investigational drug within
             the 90 days prior to screening.

          2. Subjects who were likely to be noncompliant with the protocol, or who were felt to be
             unsuitable by the Investigator for any other reason.

          3. Positive serologic findings for human immunodeficiency virus (HIV) antibodies,
             hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

          4. Positive findings of urine drug screen (amphetamines, barbiturates, benzodiazepines,
             cannabinoids, cocaine, methadone, opiates, MDMA [3,4-ethylenedioxymethamphetamine;
             ecstasy]).

             Medical History

          5. Any significant cardiovascular, hepatic, renal, respiratory (e.g. childhood asthma),
             gastrointestinal, endocrine (e.g. diabetes,), immunological, dermatological,
             haematological, neurological, or psychiatric disease and history thereof.

          6. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before
             study Day 1.

          7. History of drug abuse within 1 year before study Day 1.

          8. 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).

          9. History of any clinically important drug allergy.

         10. Had previously received BIA 9-1067.

             Prohibited treatments and dietary restrictions

         11. 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.

         12. 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.

         13. Donation of blood (i.e. 450 ml) within 60 days before study Day 1.

             Young subjects only:

             Prohibited treatments and dietary restrictions

         14. Prohibited Treatments: use of any investigational drug within 90 days (young and
             elderly subjects) or prescription drug within 30 days before investigational medical
             product (IMP) administration.

             Elderly subjects only:

             Prohibited treatments and dietary restrictions

         15. For elderly subjects, previously prescribed medications that do not interfere with
             absorption, distribution, metabolism, and excretion or safety/tolerability evaluation
             of BIA 9-1067 and adrenal or renal function were allowed if the dose regimen had been
             stable for at least 4 weeks and was expected to remain stable throughout the study.
             Such concomitant medications was reviewed and mutually agreed upon by the sponsor and
             the investigator.