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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00543075
First received: October 10, 2007
Last updated: March 11, 2012
Last verified: June 2008
  Purpose

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
  Eligibility

Ages Eligible for Study:   18 Weeks and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543075

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

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov 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
Adult
Genasense
oblimersen
G3139
Genta
Pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014