NCT01879748

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline

A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Rasagiline	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)
DRUG	Placebo	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)

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2013-06-18
• Last updated: 2013-12-20

Locations

1 site across 1 country: United States