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COMPLETEDPhase 1NCT00442871

Study Of SB-497115 in Healthy Subjects and Subjects With Mild, Moderate or Severe Renal Impairment

The main purpose of this study is to compare how one 50 mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. The study i...

Lead sponsor: GlaxoSmithKline•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy or have renal impairment
•Females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy
•Negative drug, alcohol, and HIV tests.

Exclusion Criteria

•Taking a medication or therapy not approved by the study doctor
•Rapidly changing kidney function
•Drug or alcohol abuse within past 6 months
•Used an investigational drug in the past 30 days
•Females who are pregnant or nursing
•Have active hepatitis B or C

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 13, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment29

Start dateSep 2006

Last updatedNov 13, 2017

Condition

Purpura, Thrombocytopaenic, Idiopathic

Locations shown

GSK Investigational Site

Gainesville, Florida

GSK Investigational Site

Saint Paul, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2017Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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