NCT00491998

PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral Tablets

Randomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral Tablets

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Vernalis (R&D) Ltd · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if the pharmacokinetic profile of V1512 is similar or better than existing medications for the treatment of Parkinson's Disease

Detailed description

The pharmacokinetics of V1512 effervescent tablet has been evaluated in healthy volunteers, however not fully in PD patients. This study aims to evaluate the PK profiles in PD patients of different dosing schedules of V1512 effervescent tablet compared to the profiles after standard L-dopa/carbidopa (Sinemet) over the course of the day. Two dosing schedules have been chosen to evaluate a possible relation between dosing interval and 'ON' time, with and without associated dyskinesia. Similar dosing schedules with the comparator Sinemet are commonly employed in the treatment of fluctuating PD patients. Patients assigned to cohort 3 will also take a dose of entacapone concomitantly with each dose of V1512 or Sinemet, thereby allowing the kinetics and dynamics of.V1512 and Sinemet to be compared in the presence of COMT inhibition. Safety and tolerability of the dosing regimens in patients will also be assessed further in this double-blind study

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	V1512	6 doses of IMP at 2-hourly intervals
DRUG	V1512	3-hourly dosing
DRUG	V1512 and Entacapone	4 doses of IMP and Entacapone at 3-hourly intervals

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-06-27
• Last updated: 2011-07-25

Locations

1 site across 1 country: Italy