A Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients

Study Overview
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Brief Summary
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An open label phase I/IIa study to evaluate the safety and tolerability of 6 different doses/ infusion rates of subcutaneous (SC) ND0612 solution in PD patients; to determine if continuous delivery of levodopa and carbidopa can provide reduced variability in plasma concentration; to test and compare the PK profile of high and low concentrations of CD; to assess preliminary efficacy.

Official Title
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A Phase I/II Pharmacokinetic (PK) Study of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD), Delivered as a Continuous Subcutaneous in Parkinson's Disease (PD) Patients Treated With LD

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Levodopa and carbidopa SC solution
* Drug: Oral levodopa and carbidopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female PD patients of any race aged 30 to 80 years PD diagnosis consistent with the UK PD Society Brain Bank criteria. Stable doses of anti PD drugs for at least 30 days PD patients with well-defined morning OFF and a good response to LD MMSE score > 26 No clinically significant medical, psychiatric or laboratory abnormalities Exclusion Criteria: Atypical or secondary Parkinsonism. Acute psychosis or hallucinations. Subjects treated with neuroleptics History of melanoma or significant skin disorders. Prior neurosurgical procedure for PD. Patients with a history of drug abuse or alcoholism Clinically significant ECG abnormalities. Renal or liver dysfunction Subjects who have participated in another clinical study within 30 days

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ND0612<br>Levodopa and carbidopa SC solution | Drug: Levodopa and carbidopa SC solution<br>* Levodopa and carbidopa SC solution<br>* Other names: ND0612;|
| Active Comparator: Oral levodopa and carbidopa<br>Oral levodopa and carbidopa | Drug: Oral levodopa and carbidopa<br>* Oral levodopa and carbidopa<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events frequency |  | Up to 6 weeks | 
| LD, CD and 3-OMD PK analysis from sample taken on Days 3, 4 and 5 will be used to determine the Fluctuation Index, its CV, AUC, Cmin, Cmax, and tmax. |  | Days 1, 2, 3 and 4 | 
| Tolerability: Number of patients who discontinued due to adverse events |  | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor fluctuations, levodopa pharmacokinetics, levodopa and carbidopa solution, continuous subcutaneous delivery