Parkinson's Disease
Conditions
Brief summary
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
Interventions
DRUGND0611
Continuous delivery of ND0611
Sponsors
NeuroDerm Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | — | Safety and tolerability: * Adverse event reporting * Discontinuation of the treatment due to adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | — | Pharmacokinetic profile of plasma LD and CD: * Primary endpoint: t½ * Secondary endpoints: through levels, Cmax, Tmax, AUC |
Countries
Israel
Outcome results
None listed