A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics
The objective of this study is to investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is to assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen.
For that purpose, all study participants will undergo intensive blood sampling for investigation of levodopa levels and various tolerability examinations, such as the measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and questioning to find out how the study participants are feeling. Furthermore, blood samples will be drawn and urine tests will be performed repeatedly for safety purpose during the course of the study.
The results of this clinical trial may be used for the drug registration of safinamide in the future.
|Idiopathic Parkinson's Disease||Drug: Safinamide + Levodopa Other: Placebo + Levodopa||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
|Official Title:||A Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's Disease|
- AUC and Cmax of Levodopa [ Time Frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period. ]
- tmax, CL, t1/2 of Levodopa [ Time Frame: Main pharmacocinetics measurements will be taken at Day 1 and 6 of each period. ]
|Study Start Date:||September 2009|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|Experimental: Safinamide + Levodopa||
Drug: Safinamide + Levodopa
Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
|Placebo Comparator: Placebo + Levodopa||
Other: Placebo + Levodopa
Treatment B: Placebo matching 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026428
|Study Director:||Sonja Krösser, PhD||Merck KGaA|