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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Normal Renal Function Mildly Impaired Renal Function Moderately Impaired Renal Function

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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Genasense (oblimersen, G3139)

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

Intervention Type DRUG

Other Intervention Names

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Oblimersen G3139

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes