Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Carbidopa
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to the effect of three single oral doses of nebicapone (50 mg,
      100 mg and 200 mg) on the levodopa pharmacokinetics when administered in combination with a
      single-dose of controlled release levodopa 200 mg/carbidopa 50 mg (Sinemet CR 200/50).
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled, 4-way crossover study with four
      single-dose treatment periods. The washout period between doses was 5 days or more.

      Procedures:

      Screening: Subjects will be screened for eligibility within 28 and 7 days of first admission.
      Written informed consent will be obtained before any study procedure is performed. The
      screening will consist of: medical history; physical examination, vital signs; complete
      neurological examination; 12-lead ECG; hematology, coagulation, plasma biochemistry and
      urinalysis tests; HIV, hepatitis B and hepatitis C serology; drugs of abuse and alcohol
      screen; urine pregnancy test in women of childbearing potential; and review of the selection
      criteria. The results of screening must be known to the investigator prior to the subject's
      first admission.

      Treatment periods: In each of the four consecutive treatment periods, eligible subjects will
      be admitted to the UFH on the day prior to receiving the study medication for: vital signs;
      medical history and physical examination updates; 12-lead ECG; hematology and plasma
      biochemistry; drugs of abuse and alcohol screen; and urine pregnancy test in women of
      childbearing potential. On the first admission the subjects will have a review of the
      selection criteria and will be randomized to one of the treatment sequences. On the morning
      of the dosing day, subjects will receive a dose of BIA 3-202 / Placebo concomitantly with a
      dose of Sinemet CR 200/50 in fasting conditions (at least 8 hours) and will remain in the UFH
      until at least 24 h post-dose; then, they will be discharged and will return for the next
      period or the follow-up visit. At given time-points between pre-dose and discharge, subjects
      will be submitted to vital signs recording, brief neurological examinations, 12-lead ECG, and
      blood sampling for plasma drug assays and erythrocyte S-COMT activity. At discharge, vital
      signs and ECG will be recorded, and hematology and plasma biochemistry tests will be
      performed.

      Follow-up: A follow-up visit will occur approximately 7-10 days after discharge of the last
      treatment period or early discontinuation for: medical history and physical examination
      updates; vital signs; 12-lead ECG; hematology, plasma biochemistry and urinalysis tests; and
      pregnancy test in women of childbearing potential.
    

Intervention name(s): BIA 3-202; Placebo; Sinemet®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nebicapone tablets 50 mg, oral administration; Nebicapone matching placebo tablets; Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg) tablets
Other intervention name(s): Nebicapone
Intervention MeSH terms: Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment