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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: ND0611
* Drug: ND0611


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ND0611 dose 1, ND0611 dose 2, placebo<br> | Drug: ND0611<br>* Continuous delivery of ND0611<br>Drug: ND0611<br>* Solution of ND0611 delivered continuously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Safety and tolerability: Adverse event reporting Discontinuation of the treatment due to adverse event |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Pharmacokinetic profile of plasma LD and CD: Primary endpoint: t½ Secondary endpoints: through levels, Cmax, Tmax, AUC |  |