Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611

Parkinson's Disease Clinical Trial

Official title:

A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103011
• Other study ID #: ND0611/001
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2010
• Last updated: October 3, 2010
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2010
• Source: NeuroDerm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is that continuous ND0611 increases the bioavailability of levodopa and therefore the levodopa area-under-the-concentration-curve values, half-life, and trough concentrations The study will help determining the safety and tolerability of ND0611 and determine the pharmacokinetic profile of levodopa following multiple oral dosing of levodopa/carbidopa (LD/CD) and continuous delivery of ND0611

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy Caucasian males between 18 and 50 years (inclusive) of age

• Normal body weight

• 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.

• Haemoglobin level >12.5 mg /dl

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.

• Subject with known atopic disorders

• Known allergy or hypersensitivity to adhesive tapes.

• 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ND0611
Continuous delivery of ND0611
• ND0611
Solution of ND0611 delivered continuously

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	Safety and tolerability: Adverse event reporting; Discontinuation of the treatment due to adverse event		No
Secondary	Pharmacokinetics	Pharmacokinetic profile of plasma LD and CD: Primary endpoint: t½; Secondary endpoints: through levels, Cmax, Tmax, AUC		No