NCT01142154

Pharmacokinetics and Safety Study of Single and Multiple Oral Doses Prodarsan™ in Patients With Cockayne Syndrome

A Phase I/II Crossover Study To Evaluate and Compare the Pharmacokinetics of a Single IV Dose of D-Mannitol (Osmitrol®10%) to Single and Multiple, Escalating Doses of Liquid, Oral Prodarsan™ in Patients With Cockayne Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: DNage B.V. · Industry
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This study is to compare the exposure of orally administered Prodarsan to the intravenous dosed Osmitrol (10% solution) in Cockayne Syndrome (CS) patients. Also the pharmacokinetics of single and multiple orally dosed Prodarsan will be evaluated and compared to intravenous dose of Osmitrol in CS patients.

Conditions

• Cockayne Syndrome

Interventions

Type	Name	Description
DRUG	Prodarsan	Prodarsan TID, oral solution, 6-8 days

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2011-02-01
• First posted: 2010-06-11
• Last updated: 2011-06-23

Locations

1 site across 1 country: United States