Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Intervention: BIA 9-1067 5 mg; BIA 9-1067 25 mg; levodopa/carbidopa 100/25; Placebo; levodopa/benserazide 100/25 mg
Intervention description: OPC, Opicapone; OPC, Opicapone; immediate (standard) release levodopa/carbidopa 100/25; PLC, Placebo; immediate (standard) release levodopa/benserazide
Intervention MeSH terms: Levodopa; Carbidopa; Opicapone; Benserazide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
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 determine the effect of BIA 9 1067 (5 mg, 15 mg and 50 mg) in
      steady-state conditions on the levodopa pharmacokinetics of a single dose of
      immediate-release levodopa/carbidopa 100/25 mg and of a single dose of immediate-release
      levodopa/benserazide 100/25 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  able to participate and willing to give written informed consent;

          -  male and female subjects;

          -  aged 18 to 45 years, inclusive;

          -  body mass index (BMI) between 18 and 30 kg/m2;

          -  healthy as determined by the Investigator on the basis of medical history, physical
             examination, clinical laboratory test results, vital signs, complete neurological
             examination and 12-lead electrocardiogram (ECG);

          -  negative tests for hepatitis B surface (HBs) antigen, anti-hepatitis C virus (HCV),
             human immunodeficiency virus-1 (HIV-1) and HIV-2 antibodies at screening;

          -  negative screen for drugs of abuse and alcohol at screening and admission to the
             treatment period;

          -  non-smokers or ex-smokers for at least 3 months;

          -  if sexually active, agreed to use a medically acceptable form of contraception
             throughout the study;

          -  if female of childbearing potential, had a negative human chorionic gonadotropin (HCG)
             beta serum pregnancy test at screening and admission to the treatment period.

        Exclusion Criteria:

          -  who did not conform to the above inclusion criteria, or in case of volunteers who had
             a clinically relevant surgical history, a clinically relevant family history; or who
             had a history of relevant atopy;

          -  who had a significant infection or known inflammatory process at screening or
             admission to the treatment period; acute gastrointestinal symptoms (e.g., nausea,
             vomiting, diarrhea, heartburn) at the time of screening or admission to the treatment
             period;

          -  who were vegetarians, vegans or had medical dietary restrictions;

          -  who could not communicate reliably with the Investigator;

          -  who were unlikely to co-operate with the requirements of the study; history of
             hypersensitivity to BIA 9 1067, tolcapone, entacapone, levodopa, carbidopa,
             benserazide or any related products (including excipients of the formulations) as well
             as severe hypersensitivity reactions (like angioedema) to any drugs;

          -  any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g.
             childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia),
             immunologic, dermatological, haematological, neurologic, or psychiatric disease;

          -  any clinically significant illness in the previous 28 days before day 1 of this study;
             history of drug abuse within 1 year before study day 1; history of alcoholism within 1
             year before day 1.

          -  Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12
             g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25
             cL glass of 6° [6%] beer = 15 g);

          -  poor motivation, intellectual problems likely to limit the validity of consent to
             participate in the study or limit the ability to comply with the protocol requirements
             or inability to cooperate adequately, inability to understand and to observe the
             instructions of the physician;

          -  donation of blood (i.e., 450 mL) within 60 days before study day 1;

          -  positive urine screening of ethyl alcohol or drugs of abuse upon admission to the
             treatment period;

          -  any history of tuberculosis and/or prophylaxis for tuberculosis; positive results to
             HIV, hepatitis B surface antigen (HBsAg) or anti-HCV tests;

          -  participation in any previous clinical study with BIA 9 1067;

          -  if female, being pregnant or breast-feeding.