Effect of Rasagiline on BIA 9-1067 Pharmacokinetics
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Rasagiline
Intervention description: 50 mg BIA 9-1067 (single-dose); 1 mg rasagiline (single-dose)
Intervention MeSH terms: Opicapone; Rasagiline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson Disease; BIA 9-1067

Summary:

      The purpose of this study is to investigate the effect of rasagiline on BIA 9-1067
      pharmacokinetics in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who were 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 18.0 and 30.0 kg/m2, inclusive.

          -  Subjects who were healthy as determined by pre-study medical history, physical
             examination, vital signs, complete neurological examination and 12-lead ECG.

          -  Subjects who had negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at
             screening

          -  Subjects who had clinical laboratory test results clinically acceptable at screening
             and admission to each treatment period.

          -  Subjects who had a negative screen for alcohol and drugs of abuse at screening and
             admission to each treatment period.

          -  Subjects who were 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 pregnancy test (β-HCG) at screening and admission to
             each treatment period

        Exclusion Criteria:

          -  Subjects who had 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 had a clinically relevant surgical history.

          -  Subjects who had any significant abnormality in the coagulation tests.

          -  Subjects who had any significant abnormality in the liver function tests (a
             case-by-case decision for any abnormality was to be discussed with the Sponsor before
             inclusion).

          -  Subjects who had a history of relevant atopy or drug hypersensitivity.

          -  Subjects who had a history of alcoholism or drug abuse.

          -  Subjects who consumed more than 14 units of alcohol a week.

          -  Subjects who had a significant infection or known inflammatory process at screening or
             admission to each treatment period.

          -  Subjects who had acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea,
             heartburn) at the time of screening or admission to each treatment period.

          -  Subjects who had received fluoxetine within 5 weeks of admission to the first period.

          -  Subjects who had used any other medicines within 2 weeks of admission to first period
             that could affected the safety or other study assessments, in the investigator's
             opinion.

          -  Subjects who had previously received BIA 9-1067.

          -  Subjects who have used any investigational drug or participated in any clinical trial
             within 90 days prior to screening.

          -  Subjects who have donated or received any blood or blood products within the 3 months
             prior to screening.

          -  Subjects who were vegetarians, vegans or have medical dietary restrictions.

          -  Subjects who could not communicated reliably with the investigator.

          -  Subjects who were unlikely to co-operate with the requirements of the study.

          -  Subjects who were unwilling or unable to give written informed consent.

          -  (If female) She was pregnant or breast-feeding.

          -  (If female) She was of childbearing potential and she did not use an approved
             effective contraceptive method (double-barrier, intra-uterine device) or she uses oral
             contraceptives.