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Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611

NCT ID: NCT01103011

Last Updated: 2010-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ND0611 dose 1, ND0611 dose 2, placebo

Group Type EXPERIMENTAL

ND0611

Intervention Type DRUG

Continuous delivery of ND0611

ND0611

Intervention Type DRUG

Solution of ND0611 delivered continuously

Interventions

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ND0611

Continuous delivery of ND0611

Intervention Type DRUG

ND0611

Solution of ND0611 delivered continuously

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NeuroDerm Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Neuroderm, ltd.

Locations

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Hadassah Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ND0611/001

Identifier Type: -

Identifier Source: org_study_id