NCT00543075

Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function

A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Genta Incorporated · Industry
• Sex: All
• Age: 18 Weeks
• Healthy volunteers: Accepted

Summary

To characterize the pharmacokinetics of G3139 in subjects with normal, mildly impaired, and moderately impaired renal function who receive Genasense 3 mg/kg/day by continuous intravenous infusion for 2 days (48 hours).

Conditions

• Normal Renal Function
• Mildly Impaired Renal Function
• Moderately Impaired Renal Function

Interventions

Type	Name	Description
DRUG	Genasense (oblimersen, G3139)	3 mg/kg/day by intravenous infusion for up to 48 hours

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-11-01
• Completion: 2009-09-01
• First posted: 2007-10-12
• Last updated: 2012-03-13

Locations

1 site across 1 country: United States