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

Genta Incorporated

Status and phase

Completed

Phase 1

Conditions

Normal Renal Function

Mildly Impaired Renal Function

Moderately Impaired Renal Function

Treatments

Drug: Genasense (oblimersen, G3139)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00543075

GPK104

Details and patient eligibility

About

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).

Enrollment

23 patients

Sex

All

Ages

18+ weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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