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Completed

NCT Number: NCT00543075

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

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).

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Key information

Conditions

Normal Renal Function Mildly Impaired Renal Function Moderately Impaired Renal Function

Age range

18 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genasense (oblimersen, G3139)

Drug

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

Other names: Oblimersen, G3139

Primary outcomes

  1. Pharmacokinetics of oblimersen (G3139)

    Time frame: Up to 58 hours after start of Genasense infusion

Sponsors and collaborators

Lead sponsor

Genta Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Oct 12, 2007
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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