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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01103011
• Date of registration: 12/04/2010
• Prospective Registration: No
• Primary sponsor: NeuroDerm Ltd.
• Public title: Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
• Scientific 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
• Date of first enrolment: April 2010
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01103011
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Israel

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: ND0611

Primary Outcome(s)

Safety and tolerability [Time Frame: No]

Secondary Outcome(s)

Pharmacokinetics [Time Frame: No]

Secondary ID(s)

ND0611/001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors