Trial | NCT00543075  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    23
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).
Study Started
May 31
2006
Primary Completion
Nov 30
2007
Study Completion
Sep 30
2009
Last Update
Mar 13
2012
Estimate

Drug Genasense (oblimersen, G3139)

3 mg/kg/day by intravenous infusion for up to 48 hours

  • Other names: Oblimersen, G3139

Criteria 

Key inclusion criteria:

Age > 18 years
Adequate organ function as determined < 7 days prior to starting study medication (except for renal function, as specified per protocol)
Creatinine clearance > 80 mL/min based on the Cockcroft-Gault formula for subjects in Group 1; or 50 to less than or equal to 80 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 2; or 30 to 49 mL/min based on the Cockcroft-Gault formula and confirmed based on measured creatinine clearance for subjects in Group 3

Key exclusion criteria:

Significant medical disease
Prior organ allograft
Coexisting condition that would require the subject to continue therapy during the treatment (infusion) phase of the study with a drug known to alter renal function
No Results Posted