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Trial record 7 of 11 for:    nd0612

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01486628
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : April 1, 2016
Information provided by (Responsible Party):
NeuroDerm Ltd.

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ND0612 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : April 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 2 weeks ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01486628

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Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
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Principal Investigator: Yoseph Caraco, MD Hadassah Medical Center,Israel
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Responsible Party: NeuroDerm Ltd. Identifier: NCT01486628    
Other Study ID Numbers: ND0612/001 and 001b
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: June 2013
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases