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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo; Drug: ND0612

• Registration Number: NCT01486628
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-04
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Study Start: 2012-04-30
• Primary Completion: 2012-11-22
• Study Completion: 2013-06-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline solution for subcutaneous administration
levodopa and carbidopa	ND0612	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	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

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel