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

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

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: ND0611; Drug: ND0611

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ND0611 dose 1, ND0611 dose 2, placebo	Drug: ND0611; Continuous delivery of ND0611; Drug: ND0611; Solution of ND0611 delivered continuously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
Safety and tolerability	Safety and tolerability: Adverse event reporting; Discontinuation of the treatment due to adverse event

Secondary Outcome Measures

Outcome Measure	Measure Description
Pharmacokinetics	Pharmacokinetic profile of plasma LD and CD: Primary endpoint: t½; Secondary endpoints: through levels, Cmax, Tmax, AUC

Collaborators and Investigators

• Sponsor: NeuroDerm Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (ESTIMATE): April 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2010
• Last Update Submitted That Met QC Criteria: October 3, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ND0611/001