A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the pharmacokinetics of rasagiline in healthy Japanese and
      Caucasian subjects after single and multiple doses of rasagiline.
    

Detailed description: 
      This is a single-center, double-blind, placebo-controlled, randomized study in healthy
      Japanese and Caucasian subjects after administration of single and multiple doses of
      rasagiline. All subjects will have a screening visit within 28 days of their check-in day
      (day -1) to confirm eligibility. Eligible subjects will be admitted to the investigational
      center on study day -1 and their eligibility to participate in the study confirmed. On the
      morning of day 1, subjects will be randomly assigned to receive a daily dose of 0.5, 1, or 2
      mg of rasagiline or placebo at the same time every morning after an overnight fast (of at
      least 10 hours) on days 1 through 10. Venous blood samples (4 mL each) for pharmacokinetic
      analysis will be collected at specified time points through 24 hours after study drug
      administration on day 1 and through 48 hours after study drug administration on day 10. The
      duration of study participation for each subject will be approximately 6 weeks.
    

Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will be enrolled into 1 of 4 cohorts:
cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
Each subject will then be randomly assigned to 1 of the following groups:
rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects)
rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects)
rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects)
placebo (8 Japanese and 8 Caucasian subjects); Each subject will be enrolled into 1 of 4 cohorts:
cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
Each subject will then be randomly assigned to 1 of the following groups:
rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects)
rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects)
rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects)
placebo (8 Japanese and 8 Caucasian subjects)
Other intervention name(s): rasagiline mesylate; TVP1012; AZILECT®
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Azilect; rasagiline mesylate