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

This study has been completed.
Information provided by (Responsible Party):
Genta Incorporated Identifier:
First received: October 10, 2007
Last updated: March 11, 2012
Last verified: June 2008

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).

Condition Intervention Phase
Normal Renal Function
Mildly Impaired Renal Function
Moderately Impaired Renal Function
Drug: Genasense (oblimersen, G3139)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Pharmacokinetics of oblimersen (G3139) [ Time Frame: Up to 58 hours after start of Genasense infusion ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: May 2006
Study Completion Date: September 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Genasense (oblimersen, G3139)
    3 mg/kg/day by intravenous infusion for up to 48 hours
    Other Names:
    • Oblimersen
    • G3139

Ages Eligible for Study:   18 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00543075

United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Genta Incorporated
Principal Investigator: Harry Alcorn, PharmD Davita Clinical Research
  More Information

No publications provided

Responsible Party: Genta Incorporated Identifier: NCT00543075     History of Changes
Other Study ID Numbers: GPK104
Study First Received: October 10, 2007
Last Updated: March 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Renal Function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on April 17, 2014