NCT00543075

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 13, 2012

Status Verified

June 1, 2008

Enrollment Period

1.5 years

First QC Date

October 10, 2007

Last Update Submit

March 11, 2012

Conditions

Normal Renal FunctionMildly Impaired Renal FunctionModerately Impaired Renal Function

Keywords

Renal FunctionAdultGenasenseoblimersenG3139GentaPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of oblimersen (G3139)

    Up to 58 hours after start of Genasense infusion

Interventions

Genasense (oblimersen, G3139)DRUG

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

Also known as: Oblimersen, G3139

Eligibility Criteria

Age18 Weeks+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Interventions

oblimersen

Study Officials

  • Harry Alcorn, PharmD

    Davita Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 12, 2007

Study Start

May 1, 2006

Primary Completion

November 1, 2007

Study Completion

September 1, 2009

Last Updated

March 13, 2012

Record last verified: 2008-06

Locations

US(1)