Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; Placebo; Madopar® HBS
Intervention description: OPC, Opicapone; PLC, Placebo; controlled-release levodopa 100 mg/benserazide 25 mg
Intervention MeSH terms: Opicapone; Benserazide, levodopa drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Parkinson's disease (PD); Opicapone; BIA 9-1067

Summary:

      To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg)
      on the levodopa pharmacokinetics when administered in combination with a single-dose of
      controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects between 18 and 45 years, inclusive.

          -  Subjects of body mass index (BMI) between 19 and 30 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 clinical laboratory test results that were clinically acceptable at
             screening and admission to first treatment period.

          -  Subjects who had negative tests for hepatitis B surface antigen (HBsAg),
             anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2
             antibodies (HIV-1 and HIV-2 Ab) at screening.

          -  Subjects who had/were negative for drugs of abuse at screening and admission to each
             treatment period.

          -  Subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day.

          -  Subjects who were able and willing to give written informed consent.

        Exclusion Criteria:

          -  Subjects who did not conform to the above inclusion criteria, or

          -  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 a clinically relevant family history.

          -  Subjects who had a history of relevant atopy.

          -  Subjects who had a history of relevant drug hypersensitivity.

          -  Subjects who had a history of glaucoma.

          -  Subjects who had a history of alcoholism or drug abuse.

          -  Subjects who consumed more than 21 units of alcohol a week.

          -  Subjects who had a significant infection or known inflammatory process on screening or
             first admission.

          -  Subjects who had acute gastrointestinal symptoms at the time of screening or first
             admission (e.g., nausea, vomiting, diarrhoea, heartburn).

          -  Subjects who used medicines within 2 weeks of first admission that, in the opinion of
             the investigator, may affect the safety or other study assessments.

          -  Subjects who used any investigational drug or participated in any clinical trial
             within 2 months of their first admission.

          -  Subjects who donated or received any blood or blood products within the previous 2
             months prior to screening.

          -  Subjects who were vegetarians, vegans or have medical dietary restrictions.

          -  Subjects who could not communicate 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.

          -  Subjects who were BIAL - Portela & Cª, SA employees.