Status:
COMPLETED
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Lead Sponsor:
NeuroDerm Ltd.
Conditions:
Parkinson's Disease
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers. O...
Eligibility Criteria
Inclusion
- Healthy Caucasian males between 18 and 40 years (inclusive) of age
- Normal BMI (18.5-24.9)
- 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.
Exclusion
- 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.
- Presence of clinically significant scars or other skin disorders in the area of placement of the pump.
- 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
Key Trial Info
Start Date :
April 30 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01486628
Start Date
April 30 2012
End Date
June 13 2013
Last Update
January 18 2024
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel