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NCT00501462 · ClinicalTrials.gov registry record · Phase 1

A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function

A Phase 1 study of Diabetes Mellitus, Type 2 and Type 2 Diabetes Mellitus, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target
4
Study locations

NCT00501462 is a Phase 1 study of Diabetes Mellitus, Type 2 and Type 2 Diabetes Mellitus that has completed, run by GlaxoSmithKline. The registered enrollment target is 29 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT00501462, a Phase 1 study of Diabetes Mellitus, Type 2 and Type 2 Diabetes Mellitus, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target
4
Study locations

Study Summary

This is an open-label study that will measure blood levels of different parts of a drug called GKS189075. People participating in this study will receive a single dose of 250mg GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function will be asked to participate in this study. They will be compared to about 20 healthy participants who are close to the same age and body size. People participating in this study will stay at a clinical research unit beginning 2 days before they receive their single dose of GSK189075 and will remain there until approximately one day after receiving the study drug. During this study urine will be collected beginning the day before receiving study drug until the day after, just prior to leaving the clinical research unit. Blood samples will also be collected at various times beginning immediately before until 24 hours after receiving the study drug.

Conditions Studied

Diabetes Mellitus, Type 2 Type 2 Diabetes Mellitus Renal Insufficiency

Interventions

  • DRUG GSK189075

Study Locations (4)

Florida

  • GSK Investigational Site - Orlando

Minnesota

  • GSK Investigational Site - Minneapolis

Tennessee

  • GSK Investigational Site - Knoxville

Texas

  • GSK Investigational Site - Austin

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2007-07
Est. Completion 2008-03
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00501462

The ClinicalTrials.gov registry entry for NCT00501462 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which GSK189075 is the first listed.

NCT00501462 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Florida, Minnesota, Tennessee.

Frequently Asked Questions

What is clinical trial NCT00501462 about?

NCT00501462 is a clinical study titled "A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function". This is an open-label study that will measure blood levels of different parts of a drug called GKS189075. People participating in this study will receive a single dose of 250mg GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function will be asked to participate ...

What is the current status of trial NCT00501462?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-07. Estimated completion is 2008-03.

What conditions does trial NCT00501462 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus, Renal Insufficiency.

What interventions are being tested in trial NCT00501462?

The interventions under investigation include: GSK189075 (DRUG).

Who is sponsoring clinical trial NCT00501462?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00501462 being conducted?

This trial has 4 study locations across Florida, Minnesota, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.