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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486628
• Other study ID #: ND0612/001 and 001b
• Status: Completed
• Phase: Phase 1
• Start date: April 30, 2012
• Est. completion date: June 13, 2013

Study information

• Verified date: January 2024
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 13, 2013
• Est. primary completion date: November 22, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
NeuroDerm Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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