drugset / Trial / NCT01486628

Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers

NCT01486628

Phase 1 Completed 36 enrolled NeuroDerm Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

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: 1. the maximal tolerated dose of SC ND-0612 2. 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.

Timeline

Start
2012-04-30
Primary completion
2012-11-22
Completion
2013-06-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbidopa Unknown Subcutaneous
Comparator Levodopa Small molecule Subcutaneous

Indications