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

Sponsor

NeuroDerm Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01103011

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: ND0611 Drug: ND0611	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ND0611 dose 1, ND0611 dose 2, placebo	Drug: ND0611 Continuous delivery of ND0611 Drug: ND0611 Solution of ND0611 delivered continuously

Arm

Intervention/Treatment

Experimental: ND0611 dose 1, ND0611 dose 2, placebo

Drug: ND0611

Continuous delivery of ND0611

Drug: ND0611

Solution of ND0611 delivered continuously

Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Center	Jerusalem		Israel

Sponsors and Collaborators

NeuroDerm Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01103011

Other Study ID Numbers:

ND0611/001

First Posted:

Apr 13, 2010

Last Update Posted:

Oct 5, 2010

Last Verified:

Apr 1, 2010

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Oct 5, 2010