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NCT00501930 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers

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

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT00501930 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 12 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00501930, 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
12 participants
Enrollment target
1
Study location

Study Summary

This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.

Interventions

  • DRUG GSK189075

Study Locations (1)

Wisconsin

  • GSK Investigational Site - Madison

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2007-04
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00501930

The ClinicalTrials.gov registry entry for NCT00501930 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 (100% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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

NCT00501930 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT00501930 about?

NCT00501930 is a clinical study titled "A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers". This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer...

What is the current status of trial NCT00501930?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2007-04.

What conditions does trial NCT00501930 study?

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

What interventions are being tested in trial NCT00501930?

The interventions under investigation include: GSK189075 (DRUG).

Who is sponsoring clinical trial NCT00501930?

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

Where is trial NCT00501930 being conducted?

This trial has 1 study location across Wisconsin. 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

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