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

May 31, 2012 updated by: GlaxoSmithKline

A Randomized, Placebo-Controlled, Double-Blind, Repeat Dose, Dose Escalation Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Supratherapeutic Doses of GSK189075 Administered for 3 Days in 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
  • written consent given
  • agreement to follow specific requirements of birth control during participation.

Exclusion Criteria:

  • history of drug or alcohol abuse within one year of the study screening.
  • use of tobacco or nicotine-containing products with 6 months prior to the study screening.
  • use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
  • blood donation within 56 days before the start of the study
  • receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical laboratory tests, ECGs, adverse events
Time Frame: screening, Day -1 - 3 all periods, follow up
screening, Day -1 - 3 all periods, follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
blood plasma levels of GSK189075
Time Frame: Day 3
Day 3
clinical lab tests
Time Frame: each day
each day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Registration Dates

First Submitted

July 13, 2007

First Submitted That Met QC Criteria

July 13, 2007

First Posted (ESTIMATE)

July 16, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KG2109799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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