Back to resultsSafety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ND0611
ND0611
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 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
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ND0611 dose 1, ND0611 dose 2, placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability
Safety and tolerability:
Adverse event reporting
Discontinuation of the treatment due to adverse event
Secondary Outcome Measures
Pharmacokinetics
Pharmacokinetic profile of plasma LD and CD:
Primary endpoint: t½
Secondary endpoints: through levels, Cmax, Tmax, AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01103011
Brief Title
Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
Official Title
A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NeuroDerm Ltd.
4. Oversight
5. Study Description
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
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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ND0611 dose 1, ND0611 dose 2, placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ND0611
Intervention Description
Continuous delivery of ND0611
Intervention Type
Drug
Intervention Name(s)
ND0611
Intervention Description
Solution of ND0611 delivered continuously
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Safety and tolerability:
Adverse event reporting
Discontinuation of the treatment due to adverse event
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Description
Pharmacokinetic profile of plasma LD and CD:
Primary endpoint: t½
Secondary endpoints: through levels, Cmax, Tmax, AUC
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
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