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

NeuroDerm

Status and phase: Completed; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: ND0612

Study type: Interventional

Funder types: Industry

Identifiers

NCT01486628

ND0612/001 and 001b

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

levodopa and carbidopa

Placebo Comparator group

Treatment:

Drug: ND0612

Placebo

Placebo Comparator group

Description:

Saline solution for subcutaneous administration

Treatment:

Drug: Placebo