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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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™

Brief 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.

Detailed Summary:
Sponsor: DNage B.V.

Current Primary Outcome: Evaluate and compare the pharmacokinetics of D-mannitol following a single IV dose of Osmitrol to single and multiple oral doses of Prodarsan in pediatric patients with Cockayne Syndrome [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the safety and tolerability of administering oral Prodarsan in CS patients over a six (6) to eight (8) day period, including dose escalation to reach a Target Dose [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: DNage B.V.

Dates:
Date Received: May 20, 2010
Date Started: June 2010
Date Completion:
Last Updated: June 22, 2011
Last Verified: June 2011