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OpenTrials
Completed

NCT Number: NCT00501397

A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers

The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time. It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Columbus, Ohio, 43212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are a healthy, non-smoking male or female.
  • Are 18 to 55 years old, inclusive.
  • Have a body weight of > or equal to 110 pounds.
  • Are a female who is unable to have any more children and have a negative pregnancy test.
  • Are willing and able to provide written informed consent before the start of any study-related procedures.
  • Are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.

Exclusion criteria

  • Smoke or use any tobacco products.
  • Have a known allergic reaction to ketoconazole or study drug.
  • Have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
  • Have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
  • Have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
  • Have donated a pint of blood within 56 days before the first dose of study drug.
  • Have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
  • Have abnormal liver test results.
  • Have a documented history or diagnosis of cirrhosis.
  • Have positive results for hepatitis C or B, or HIV at screening.
  • Have blood pressure outside of the normal range.
  • Are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
  • Are using non-prescription drugs, vitamins, herbal or dietary supplements (including St John's Wort) within 7 days before the first dose of study medication,
  • Have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.

Treatment and study plan

Ketoconazole

Drug

GSK189075

Drug

Other names: ketoconazole

Primary outcomes

  1. Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3

    Time frame: at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume

  2. urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3.

    Time frame: at Day 1 Session 1, Days 5 & 6 Session 3.

Secondary outcomes

  1. Adverse events: all visits

    Time frame: all visits

  2. ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3

    Time frame: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3

  3. Labs:followup

    Time frame: followup

  4. Urine: Day 1 Session 1,Days 5-6 Session 3

    Time frame: Day 1 Session 1,Days 5-6 Session 3

  5. Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup

    Time frame: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075

Important dates

Study start
2007
First posted
Jul 16, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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