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

This study has been completed.
Sponsor:
Information provided by:
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01103011
First received: April 12, 2010
Last updated: October 3, 2010
Last verified: April 2010

April 12, 2010
October 3, 2010
April 2010
October 2010   (final data collection date for primary outcome measure)
Safety and tolerability [ Designated as safety issue: No ]

Safety and tolerability:

  • Adverse event reporting
  • Discontinuation of the treatment due to adverse event
Same as current
Complete list of historical versions of study NCT01103011 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Designated as safety issue: No ]

Pharmacokinetic profile of plasma LD and CD:

  • Primary endpoint: t½
  • Secondary endpoints: through levels, Cmax, Tmax, AUC
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: ND0611
    Continuous delivery of ND0611
  • Drug: ND0611
    Solution of ND0611 delivered continuously
Experimental: ND0611 dose 1, ND0611 dose 2, placebo
Interventions:
  • Drug: ND0611
  • Drug: ND0611
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01103011
ND0611/001
Not Provided
Sheila Oren MD, VP Clinical and Regulatory Affairs, Neuroderm, ltd.
NeuroDerm Ltd.
Not Provided
Not Provided
NeuroDerm Ltd.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP