Mildly Impaired Renal Function, Moderately Impaired Renal Function, Normal Renal Function
Conditions
Keywords
Renal Function, Adult, Genasense, oblimersen, G3139, Genta, Pharmacokinetics
Brief 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).
Interventions
DRUGGenasense (oblimersen, G3139)
3 mg/kg/day by intravenous infusion for up to 48 hours
Sponsors
Genta Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Weeks to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of oblimersen (G3139) | Up to 58 hours after start of Genasense infusion |
Countries
United States
Outcome results
None listed