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

This study has been completed.
Information provided by:
NeuroDerm Ltd. Identifier:
First received: April 12, 2010
Last updated: October 3, 2010
Last verified: April 2010

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

Condition Intervention Phase
Parkinson's Disease
Drug: ND0611
Phase 1

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

Resource links provided by NLM:

Further study details as provided by NeuroDerm Ltd.:

Primary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: No ]

    Safety and tolerability:

    • Adverse event reporting
    • Discontinuation of the treatment due to adverse event

Secondary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]

    Pharmacokinetic profile of plasma LD and CD:

    • Primary endpoint: t½
    • Secondary endpoints: through levels, Cmax, Tmax, AUC

Estimated Enrollment: 8
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ND0611 dose 1, ND0611 dose 2, placebo Drug: ND0611
Continuous delivery of ND0611
Drug: ND0611
Solution of ND0611 delivered continuously


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01103011

Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
NeuroDerm Ltd.
  More Information

No publications provided

Responsible Party: Sheila Oren MD, VP Clinical and Regulatory Affairs, Neuroderm, ltd. Identifier: NCT01103011     History of Changes
Other Study ID Numbers: ND0611/001
Study First Received: April 12, 2010
Last Updated: October 3, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 14, 2014