Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01486628|
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : April 1, 2016
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers.
Objectives are to determine:
- the maximal tolerated dose of SC ND-0612
- the steady state plasma concentration of LD and CD following SC ND-0612 administration.
Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: ND0612 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
|Placebo Comparator: levodopa and carbidopa||
levodopa and carbidopa solution for subcutaneous administration
Placebo Comparator: Placebo
Saline solution for subcutaneous administration
Saline solution for SC continuous administration
- Safety and tolerability [ Time Frame: 2 weeks ]
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
- Incidence and frequency of local adverse events related to the ND0612 Sc administration.
- Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486628
|Hadassah Medical Center|
|Principal Investigator:||Yoseph Caraco, MD||Hadassah Medical Center,Israel|