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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

November 30, 2013

Conditions
Parkinson's Disease
Interventions
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)"

Trial Locations (1)

Unknown

Teva Investigational Site 10738, Glendale

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01879748 - A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Rasagiline | Biotech Hunter | Biotech Hunter