Trial | NCT01103011  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    carbidopa ...

  • Study Participants

    8
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
Study Started
Apr 30
2010
Primary Completion
Oct 31
2010
Study Completion
Oct 31
2010
Last Update
Oct 05
2010
Estimate

Drug ND0611

Continuous delivery of ND0611

Drug ND0611

Solution of ND0611 delivered continuously

ND0611 dose 1, ND0611 dose 2, placebo Experimental

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
No Results Posted