Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
This study is currently recruiting participants.
Verified November 2012 by NeuroDerm Ltd.
Sponsor:
NeuroDerm Ltd.
Information provided by (Responsible Party):
NeuroDerm Ltd.
ClinicalTrials.gov Identifier:
NCT01486628
First received: December 4, 2011
Last updated: November 5, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers.
Objectives are to determine:
- the maximal tolerated dose of SC ND-0612
- the steady state plasma concentration of LD and CD following SC ND-0612 administration.
Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease |
Drug: ND0612 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by NeuroDerm Ltd.:
Primary Outcome Measures:
- Safety and tolerability [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
The safety and tolerability of ND0612 will be well monitored and will assess the ND0612 effect at various doses in comparison to placebo in the following parameters:
- Incidence and frequency of local adverse events related to the ND0612 Sc administration.
- Local safety scoring. In addition, systemic adverse events and withdrawal rates and discontinuations due to adverse events will be recorded
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: levodopa and carbidopa |
Drug: ND0612
levodopa and carbidopa solution for subcutaneous administration
|
|
Placebo Comparator: Placebo
Saline solution for subcutaneous administration
|
Drug: Placebo
Saline solution for SC continuous administration
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486628
Contacts
| Contact: Sheila Oren, MD | +972542602481 | sheila@neuroderm.com |
| Contact: Irit Kopelov | +97289462729 | irit@neuroderm.com |
Locations
| Israel | |
| Hadassah Medical Center | Recruiting |
| Jerusalem, Israel | |
| Contact: Yoseph Caraco, MD 02-6779373 CARACO@hadassah.org.il | |
| Principal Investigator: Yoseph Caraco, MD | |
Sponsors and Collaborators
NeuroDerm Ltd.
Investigators
| Principal Investigator: | Yoseph Caraco, MD | Hadassah Medical Center,Israel |
More Information
No publications provided
| Responsible Party: | NeuroDerm Ltd. |
| ClinicalTrials.gov Identifier: | NCT01486628 History of Changes |
| Other Study ID Numbers: | ND0612/001 and 001b |
| Study First Received: | December 4, 2011 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Israel: Ministry of Health |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Carbidopa Levodopa |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013