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

Phase 1

Completed

• Conditions: Normal Renal Function; Mildly Impaired Renal Function; Moderately Impaired Renal Function

• Registration Number: NCT00543075
• Lead Sponsor: Genta Incorporated

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-11
• Study First Posted: 2007-10-12
• Primary Completion: 2007-11
• Status Verified: 2008-06
• Study Completion: 2009-09
• Last Update Submitted: 2012-03-11
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of oblimersen (G3139)	Up to 58 hours after start of Genasense infusion

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States