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

NeuroDerm

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease

Treatments

Drug: ND0611

Study type

Interventional

Funder types

Industry

Identifiers

NCT01103011

ND0611/001

Details and patient eligibility

About

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

Enrollment

8 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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