Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611
- Registration Number
- NCT01103011
- Lead Sponsor
- NeuroDerm Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ND0611 dose 1, ND0611 dose 2, placebo ND0611 -
- Primary Outcome Measures
Name Time Method Safety and tolerability Safety and tolerability:
* Adverse event reporting
* Discontinuation of the treatment due to adverse event
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Pharmacokinetic profile of plasma LD and CD:
* Primary endpoint: t½
* Secondary endpoints: through levels, Cmax, Tmax, AUC
Trial Locations
- Locations (1)
Hadassah Medical Center
🇮🇱Jerusalem, Israel