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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01486628
First received: December 4, 2011
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: ND0612
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 36
Study Start Date: April 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: levodopa and carbidopa Drug: ND0612
levodopa and carbidopa solution for subcutaneous administration
Placebo Comparator: Placebo
Saline solution for subcutaneous administration
Drug: Placebo
Saline solution for SC continuous administration

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486628

Locations
Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
Investigators
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Center, Israel
  More Information

No publications provided

Responsible Party: NeuroDerm Ltd.
ClinicalTrials.gov Identifier: NCT01486628     History of Changes
Other Study ID Numbers: ND0612/001 and 001b
Study First Received: December 4, 2011
Last Updated: June 6, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pharmaceutical Solutions
Levodopa
Carbidopa
Therapeutic Uses
Pharmacologic Actions
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014