Last updated: 11/04/2018 08:30:57

A Study of the effects of ketoconazole taken orally has on the PK profiles of a dose of GSK189075 in healthy volunteers

GSK study ID
KG2108197
Clinicaltrials.gov ID
NCT00501397
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

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

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

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

Secondary outcomes:

Adverse events: all visits

Timeframe: all visits

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

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

Labs:followup

Timeframe: followup

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

Timeframe: Day 1 Session 1,Days 5-6 Session 3

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

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

Interventions:
  • Drug: ketoconazole
  • Drug: GSK189075
    • Enrollment:
    22
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Type 2 Diabetes Mellitus
    Product
    remogliflozin etabonate
    Collaborators
    Not applicable
    Study date(s)
    February 2007 to March 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Are a healthy, non-smoking male or female.
    • Are 18 to 55 years old, inclusive.
    • Smoke or use any tobacco products.
    • Have a known allergic reaction to ketoconazole or study drug.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43212
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-09-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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