A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients

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

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.

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.

Main Inclusion Criteria:

• Men and women with idiopathic Parkinson's disease
• Subjects must experience motor fluctuations associated with LD/CD dosing
• Modified Hoehn and Yahr stage < 5
• Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
• Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
• Subjects must be age 30 or older.
• Subjects must be willing and able to give informed consent.

Main Exclusion Criteria:

• Subjects with a clinically significant or unstable medical or surgical condition
• Subjects with clinically significant psychiatric illness.
• Pre-menopausal women, not using birth control method.
• Subjects who have taken experimental medications within 60 days prior to baseline.
• Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).