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CompletedNCT00501397Updated Jun 4, 2012

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

A Phase 1 interventional study of ketoconazole and GSK189075 in Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2

Keywords

  • ketoconazole,
  • drug interaction,
  • pharmacokinetics
  • T2DM,
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,561 studies on the registry; 116 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Interventions

  • Drugketoconazole
  • DrugGSK189075

    Also known as: ketoconazole

06

What researchers measure

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

07

Study locations

1 site
  • GSK Investigational Site
    Columbus, Ohio 43212, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00501397
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 16, 2007
Start date
Feb 2007
Last update
Jun 4, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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