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

Normal Renal Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543075
• Other study ID #: GPK104
• Status: Completed
• Phase: Phase 1
• First received: October 10, 2007
• Last updated: March 11, 2012
• Start date: May 2006
• Est. completion date: September 2009

Study information

• Verified date: June 2008
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2009
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Weeks and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

Drug:
• Genasense (oblimersen, G3139)
3 mg/kg/day by intravenous infusion for up to 48 hours

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of oblimersen (G3139)		Up to 58 hours after start of Genasense infusion	No