Back to resultsStudy of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ND0612
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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 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.
- 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
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
levodopa and carbidopa
Placebo
Arm Description
Saline solution for subcutaneous administration
Outcomes
Primary Outcome Measures
Safety and tolerability
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
Incidence and frequency of local adverse events related to the ND0612 Sc administration.
Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486628
Brief Title
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Official Title
A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Objectives are to determine:
the maximal tolerated dose of SC ND-0612
the steady state plasma concentration of LD and CD following SC ND-0612 administration.
Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
levodopa and carbidopa
Arm Type
Placebo Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution for subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
ND0612
Intervention Description
levodopa and carbidopa solution for subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline solution for SC continuous administration
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
Incidence and frequency of local adverse events related to the ND0612 Sc administration.
Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoseph Caraco, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
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