Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611

A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611

The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611

Inclusion Criteria:

• Healthy Caucasian males between 18 and 50 years (inclusive) of age
• Normal body weight
• Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
• Subjects must be able to adhere to the protocol requirements
• Subjects must provide written informed consent to participate in the study.
• Haemoglobin level >12.5 mg /dl

Exclusion Criteria:

• History of significant psychiatric disorder, neurological diseases or sleep disorders
• History of significant systemic diseases, by medical history or tests performed during screening examinations
• Clinically significant laboratory tests at screening
• History of drug or alcohol abuse.
• Allergy to levodopa, carbidopa or any inactive component of the test formulation.
• Subjects with dark skin
• Subjects with skin diseases or neoplasms
• Subjects with narrow-angle glaucoma
• Subjects with significant allergic response to other drugs.
• Subject with known atopic disorders
• Known allergy or hypersensitivity to adhesive tapes.
• Use of any prescription or over-the-counter (OTC) medications
• Subjects who donated blood or received blood, in the last 3 months
• Participation in another clinical trial in the last 30 days
• Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures