A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067; BIA 9-1067; BIA 9-1067; Placebo; Levodopa/Carbidopa; Levodopa/Benzerazide
Intervention description: BIA 9-1067 - 25 mg single-dose; BIA 9-1067 - 50 mg single-dose; BIA 9-1067 - 100 mg single-dose; single-dose; Levodopa 100 mg Carbidopa 25 mg; Levodopa 100 mg Benzerazide 25 mg
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; BIA 9-1067

Summary:

      The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa
      pharmacokinetics when administered in combination with immediate release levodopa/carbidopa
      or levodopa/benserazide in Parkinson's Disease (PD) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of non-childbearing potential (by reason of surgery or postmenopausal);

          -  Aged between 30 and 75 years, inclusive;

          -  A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia
             and at least one of the following: muscular rigidity, rest tremor and postural
             instability);

          -  Predictable signs of end-of-dose deterioration despite "optimal" levodopa/carbidopa or
             levodopa/benserazide therapy;

          -  Been treated with a stable regimen of 3 to 8 doses of standard release 100 mg/25 mg
             levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide per day within at least 1 week
             prior to randomisation;

          -  Modified Hoehn and Yahr stage of less than 5 in the off-state;

          -  Mean duration of OFF stage ≥ 1.5 h during waking hours (based on historical
             information);

          -  Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or
             tolcapone) in stable doses for at least 4 weeks prior to randomisation;

          -  Results of clinical laboratory tests acceptable by the investigator (not clinically
             significant for the well-being of the subject or for the purpose of the study);

          -  Able and willing to give written informed consent.

        Exclusion Criteria:

          -  Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism,
             Parkinson-plus syndrome);

          -  Treated with levodopa/carbidopa or levodopa/benserazide in a 10:1 ratio, or with
             levodopa/carbidopa in a controlled-release formulation;

          -  Treated with entacapone, tolcapone, neuroleptics, antidepressants (except
             serotonin-specific reuptake inhibitors or imipramines [desipramine, imipramine,
             clomipramine and amitriptyline]), monoamine oxidase inhibitors (except selegiline up
             to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or
             rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 4 weeks prior to
             randomisation;

          -  Treated with apomorphine within 7 days prior to randomisation;

          -  Treated with any investigational product within 2 months prior to randomisation (or
             within 5 half-lives, whichever is longer);

          -  A psychiatric or any medical condition that might place him/her at increased risk or
             interfere with assessments;

          -  Known hypersensitivity to any of the ingredients of the investigational products;

          -  A history of abuse of alcohol, drugs or medications within the last 2 years;

          -  A clinically relevant ECG abnormality;

          -  A history or current evidence of heart disease, including but not limited to
             myocardial infarction, angina, congestive heart failure and cardiac arrhythmia;

          -  Unstable concomitant disease being treated with changing doses of medication;

          -  A history or current evidence of any relevant disease in the context of this study,
             i.e., with respect to the safety of the subject (e.g., hepatic or renal impairment) or
             related to the study conditions;

          -  A test positive for the human immunodeficiency viruses (HIV) 1 or 2 antibodies, or
             hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb);

          -  Donated blood or received blood or blood products within the 6 months prior to
             randomisation;

          -  Pregnant, breast-feeding or of childbearing potential;

          -  Other condition or circumstance that, in the opinion of the investigator, may
             compromise the subject's ability to comply with the study protocol.