Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Placebo
Intervention description: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).; once-daily
Intervention MeSH terms: Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson Disease; BIA 9-1067

Summary:

      To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or nonlactating and nonpregnant women;

          -  Caucasian or Japanese subjects. Caucasian subjects are subjects of European descent;
             Japanese subjects must be first or second generation. Generations will be defined as
             follows:

               1. First generation Japanese are subjects who may be living outside Japan but were
                  born in Japan to parents of Japanese descent.

               2. Second generation Japanese are subjects who were born outside of Japan to first
                  generation Japanese parents.

          -  Aged 18 to 65 years;

          -  Body weight ≥50 kg;

          -  Within BMI range 18.5 to 30 kg/m2, inclusive;

          -  Healthy, as determined by the Investigator on the basis of medical history, physical
             examination, clinical laboratory test results, vital signs, and 12-lead ECG.
             Creatinine and ALT levels must be strictly within the normal range for eligibility at
             Check-in;

          -  Women of nonchildbearing potential must be surgically sterile (hysterectomy,
             oophorectomy, or tubal ligation) or postmenopausal for ≥1 year;

          -  Women of childbearing potential must be using an effective nonhormonal method of
             contraception (intrauterine device or intrauterine system; condom or occlusive cap
             [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or
             suppository; true abstinence; or vasectomized male partner, provided that he is the
             sole partner of that subject) for a period of at least 1 month before and after dose
             administration. Women of childbearing potential must have a negative pregnancy test
             result within 48 hours before the start of the first investigational medicinal product
             (IMP) administration. Hormonal contraceptives will not be allowed because the effect
             of BIA 9 1067 on the metabolism of hormonal contraceptives and vice versa is not yet
             known;

          -  Nonsmokers, defined as having smoked ≤10 cigarettes per week for the 3 months prior to
             dosing, abstained from smoking for 7 days prior to Check-in, and having a negative
             cotinine level ≤500 ng/mL at Check-in;

          -  Have a high probability for compliance with and completion of the study, in the
             opinion of the Investigator;

          -  Able to comprehend and willing to sign an ICF.

        Exclusion Criteria:

          -  Presence or history of any disorder that may prevent the successful completion of the
             study;

          -  History of multiple and/or severe allergies to drugs or foods or a history of
             anaphylactic reactions;

          -  Known or suspected allergy or other adverse drug reactions to the trial product or
             related products (eg, tolcapone or entacapone);

          -  History of alcoholism or excessive daily alcohol consumption within the past year.
             Excessive alcohol consumption is regarded as an average weekly intake of more than 14
             units for women and 21 units for men (1 unit of alcohol = 8 to 10 g and is
             approximately equivalent to 1 glass of wine or 250 mL of beer or a standard measure of
             spirits);

          -  Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
             endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease,
             as judged by the Investigator or Sponsor's Medical Monitor;

          -  Any clinically important deviation from normal limits in physical examination, vital
             signs, or 12-lead ECGs, as judged by the Investigator or Sponsor's Medical Monitor;

          -  Acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days of Study Day
             1;

          -  Positive serologic findings for HIV antibodies, hepatitis B surface antigen (HBsAg),
             and/or hepatitis C virus antibodies (anti-HCV);

          -  Positive screen for drugs of abuse and alcohol;

          -  Recent history or presence of any disorder that may interfere with the absorption,
             distribution, metabolism, or excretion of BIA 9 1067;

          -  Positive pregnancy test result for WOCBP only;

          -  Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola),
             grapefruit, grapefruit-containing products, or alcoholic beverages from 48 hours
             before Study Day 1 until Discharge (Day 16);

          -  Involvement in other investigational studies of any type within 30 days of BIA 9-1067
             administration;

          -  Donation of blood within 90 days of Study Day 1;

          -  Use of any prescription drug within 30 days of IMP administration unless deemed
             acceptable by the Principal Investigator (PI) and Medical Monitor;

          -  Use of any over-the-counter drugs including herbal supplements (except for the
             occasional use of acetaminophen and vitamins ≤100% recommended daily allowance) within
             14 days of Study Day 1 unless deemed acceptable by the PI and Medical Monitor.