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

Parkinson's Disease Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT01879748
• Study type: Interventional
• Source: Teva Pharmaceutical Industries
• Status: Completed
• Phase: Phase 1
• Start date: June 2013
• Completion date: November 2013