Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT01486628
• Date of registration: 04/12/2011
• Prospective Registration: Yes
• Primary sponsor: NeuroDerm Ltd.
• Public title: Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
• Scientific title: A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
• Date of first enrolment: April 30, 2012
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01486628
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Israel

Contacts

• Name: Yoseph Caraco, MD
• Affiliation: Hadassah Medical Organization

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy Caucasian males between 18 and 40 years (inclusive) of age

- Normal BMI (18.5-24.9)

- 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.

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.

- Presence of clinically significant scars or other skin disorders in the area of
placement of the pump.

- 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: ND0612

Primary Outcome(s)

Safety and tolerability [Time Frame: 2 weeks]

Secondary ID(s)

ND0612/001 and 001b

Source(s) of Monetary Support

Please refer to primary and secondary sponsors