A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients

Study Overview
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Brief Summary
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A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.

Official Title
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A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Saline
* Drug: Carbidopa


Participation Criteria
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Eligibility Criteria
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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. 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).

Ages Eligible for Study
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Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Carbidopa<br> | Drug: Carbidopa<br>* Continuous 24 h administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Saline<br>* Continuous 24 h administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and frequency of adverse events, withdrawal rate | 1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events | Up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma | Pharmacokinetic profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC | Up to 2 days | 
| Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma | Pharmacokinetics profile of plasma LD and CD: Half life (t½ ), Cmax, Tmax and AUC | Up to 2 days | 

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