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

NCT01486628 | Completed Phase 1 DMC

• 1 other identifier: ND0612/001 and 001b
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.the maximal tolerated dose of SC ND-0612
2. 2.the steady state plasma concentration of LD and CD following SC ND-0612 administration.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters: * Incidence and frequency of local adverse events related to the ND0612 Sc administration. * Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded

  2 weeks

Study Arms (2)

levodopa and carbidopa

PLACEBO COMPARATOR

Drug: ND0612

Placebo

PLACEBO COMPARATOR

Saline solution for subcutaneous administration

Drug: Placebo

Interventions

ND0612 DRUG

levodopa and carbidopa solution for subcutaneous administration

levodopa and carbidopa

Placebo DRUG

Saline solution for SC continuous administration

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuroDerm Ltd.: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yoseph Caraco, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2011
• First Posted: December 6, 2011
• Study Start: April 30, 2012
• Primary Completion: November 22, 2012
• Study Completion: June 13, 2013
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

IL (1)