Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Warfarin
Intervention description: BIA 9-1067 25 mg; Warfarin 25 mg
Intervention MeSH terms: Opicapone; Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson's disease (PD); BIA 9-1067; Opicapone

Summary:

      The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the
      assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 and 30 kg/m2, inclusive.

          -  Healthy as determined by pre-study medical history, physical examination, vital signs,
             complete neurological examination and 12-lead ECG.

          -  Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.

          -  Clinical laboratory test results clinically acceptable at screening and admission to
             each treatment period.

          -  Negative screen for alcohol and drugs of abuse at screening and admission to each
             treatment period.

          -  Non-smokers or ex-smokers for at least 3 months.

          -  (If female) She was not of childbearing potential by reason of surgery or, if of
             childbearing potential, she used one of the following methods of contraception: double
             barrier or intrauterine device.

          -  (If female) She had a negative urine pregnancy test at screening and admission to each
             treatment period.

        Exclusion Criteria:

          -  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.

          -  Clinically relevant surgical history.

          -  Personal or family history of haemostatic disorder.

          -  Personal or family history of bleeding complications after surgery or tooth
             extraction, nose or gingival bleeding, or haemorrhagic diathesis.

          -  Any abnormality in the coagulation tests.

          -  Any abnormality in the liver function tests.

          -  A history of relevant atopy or drug hypersensitivity.

          -  History of alcoholism or drug abuse.

          -  Consumed more than 14 units of alcohol a week.

          -  Significant infection or known inflammatory process at screening or admission to each
             treatment period.

          -  Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the
             time of screening or admission to each treatment period.

          -  Had used medicines within 2 weeks of admission to first period that may have affected
             the safety or other study assessments, in the investigator's opinion.

          -  Had previously received BIA 9-1067.

          -  Had used any investigational drug or participated in any clinical trial within 6
             months prior to screening.

          -  Had participated in more than 2 clinical trials within the 12 months prior to
             screening.

          -  Had donated or received any blood or blood products within the 3 months prior to
             screening.

          -  Vegetarians, vegans or had medical dietary restrictions.

          -  Cannot communicate reliably with the investigator.

          -  Unlikely to co-operate with the requirements of the study.

          -  Unwilling or unable to gave written informed consent.

          -  Employees at BIAL - Portela & Co, SA.

          -  (If female) She was pregnant or breast-feeding.

          -  (If female) She was of childbearing potential and she did not used an approved
             effective contraceptive method (double-barrier or intra-uterine device) or she used
             oral contraceptives.