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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 22, 2012

Interventions

  • Drug: ND0612
    • levodopa and carbidopa solution for subcutaneous administration
  • Drug: Placebo
    • Saline solution for SC continuous administration

Arms, Groups and Cohorts

  • Placebo Comparator: levodopa and carbidopa
  • Placebo Comparator: Placebo
    • Saline solution for subcutaneous administration

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • NeuroDerm Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yoseph Caraco, MD, Principal Investigator, Hadassah Medical Organization

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