Back to resultsPharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
Primary Purpose
Normal Renal Function, Mildly Impaired Renal Function, Moderately Impaired Renal Function
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Genasense (oblimersen, G3139)
Sponsored by
About this trial
This is an interventional health services research trial for Normal Renal Function focused on measuring Renal Function, Adult, Genasense, oblimersen, G3139, Genta, Pharmacokinetics
Eligibility 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
Sites / Locations
- DaVita Clinical Research
Outcomes
Primary Outcome Measures
Pharmacokinetics of oblimersen (G3139)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543075
Brief Title
Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
Official Title
A Phase I Pharmacokinetic Study of Genasense® in Subjects With Normal Renal Function and Mildly and Moderately Impaired Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Renal Function, Mildly Impaired Renal Function, Moderately Impaired Renal Function
Keywords
Renal Function, Adult, Genasense, oblimersen, G3139, Genta, Pharmacokinetics
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Genasense (oblimersen, G3139)
Other Intervention Name(s)
Oblimersen, G3139
Intervention Description
3 mg/kg/day by intravenous infusion for up to 48 hours
Primary Outcome Measure Information:
Title
Pharmacokinetics of oblimersen (G3139)
Time Frame
Up to 58 hours after start of Genasense infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Alcorn, PharmD
Organizational Affiliation
Davita Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of Genasense in Subjects With Normal Renal Function, Mildly Impaired Renal Function, and Moderately Impaired Renal Function
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