Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Paracetamol
Intervention description: BIA 9-1067 50 mg; Paracetamol 1g
Intervention MeSH terms: Acetaminophen; Opicapone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods
      separated by a washout period of 14 days or more.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are able and willing to give written informed consent.

          -  Male or female subjects aged between 18 and 45 years, inclusive.

          -  Subjects of body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive.

          -  Subjects who are healthy as determined by pre-study medical history, physical
             examination, vital signs, complete neurological examination and 12-lead ECG.

          -  Subjects who have negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at
             screening.

          -  Subjects who have clinical laboratory test results clinically acceptable at screening
             and admission to each treatment period.

          -  Subjects who have a negative screen for alcohol and drugs of abuse at screening and
             admission to each treatment period.

          -  Subjects who are non-smokers or ex-smokers for at least 3 months.

          -  (If female) She is not of childbearing potential by reason of surgery or, if of
             childbearing potential, she uses an effective non-hormonal 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 all the duration of the study.

          -  (If female) She has a negative serum pregnancy test at screening and a negative urine
             pregnancy test on Day -1 of each treatment period.

        Exclusion Criteria:

          -  Subjects who have a clinically relevant history or presence of respiratory,
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
             dermatological, endocrine, connective tissue diseases or disorders.

          -  Subjects who have a clinically relevant surgical history.

          -  Subjects who have any clinically relevant abnormality in the coagulation tests.

          -  Subjects who have any clinically relevant abnormality in the liver function tests (a
             case-by-case decision for any abnormality must be discussed with the Sponsor before
             inclusion).

          -  Subjects who have a history of relevant atopy or drug hypersensitivity, particularly
             to paracetamol or any COMT inhibitor.

          -  Subjects who have a history of alcoholism or drug abuse.

          -  Subjects who consume more than 14 units of alcohol a week.

          -  Subjects who have a significant infection or known inflammatory process at screening
             or admission to each treatment period.

          -  Subjects who have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea,
             heartburn) at the time of screening or admission to each treatment period.

          -  Subjects who have received paracetamol within 2 weeks of admission to the first
             period.

          -  Subjects who have used any other medicines within 2 weeks of admission to first period
             that may affect the safety or other study assessments, in the investigator's opinion.

          -  Subjects who have previously received OPC.

          -  Subjects who have used any investigational drug or participated in any clinical trial
             within 90 days prior to screening.

          -  Subjects who have participated in more than 2 clinical trials within the 12 months
             prior to screening.

          -  Subjects who have donated or received any blood or blood products within the 3 months
             prior to screening.

          -  Subjects who are vegetarians, vegans or have medical dietary restrictions.

          -  Subjects who cannot communicate reliably with the investigator.

          -  Subjects who are unlikely to co-operate with the requirements of the study.

          -  Subjects who are unwilling or unable to give written informed consent.

          -  (If female) She is pregnant or breast-feeding.

          -  (If female) She is of childbearing potential and she does not use an approved
             effective contraceptive method or she uses oral contraceptives.