NCT01103011

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	ND0611	Continuous delivery of ND0611
DRUG	ND0611	Solution of ND0611 delivered continuously

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-04-13
• Last updated: 2010-10-05

Locations

1 site across 1 country: Israel