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

NCT ID: NCT01486628

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-06-13

Brief 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

levodopa and carbidopa

Group Type: PLACEBO_COMPARATOR

ND0612

Intervention Type: DRUG

levodopa and carbidopa solution for subcutaneous administration

Placebo

Saline solution for subcutaneous administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Saline solution for SC continuous administration

Interventions

ND0612

levodopa and carbidopa solution for subcutaneous administration

Intervention Type: DRUG

Placebo

Saline solution for SC continuous administration

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NeuroDerm Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoseph Caraco, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

ND0612/001 and 001b

Identifier Type: -

Identifier Source: org_study_id