A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.
Drug: levodopa and carbidopa solution for SC administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients|
- Incidence and frequency of adverse events [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
- Incidence and frequency of adverse events
- Adverse events reporting related to the ND0612 application, local safety score
- Withdrawal rate [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]Withdrawal rates and discontinuations due to adverse events
- LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]LD PK profile after oral LD dosing administered with or without ND0612:
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: levodopa and carbidopa
levodopa and carbidopa solution
|Drug: levodopa and carbidopa solution for SC administration|
Placebo Comparator: placebo to levodopa and carbidopa
Other Name: Saline
Design: single center, double-blind, randomized, placebo-controlled, crossover study.
Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.
Population: Eight (8) PD subjects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725802
|Hadassah Medical Center|