Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

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:

1. the maximal tolerated dose of SC ND-0612

2. 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NeuroDerm Ltd.
• Treatments: Carbidopa; Levodopa; Pharmaceutical Solutions

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