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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00501397
First received: July 13, 2007
Last updated: May 31, 2012
Last verified: February 2011

July 13, 2007
May 31, 2012
February 2007
Not Provided
  • 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 ]
  • 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. ]
Same as current
Complete list of historical versions of study NCT00501397 on ClinicalTrials.gov Archive Site
  • Adverse events: all visits [ Time Frame: all visits ]
  • 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 ]
  • Labs:followup [ Time Frame: followup ]
  • Urine: Day 1 Session 1,Days 5-6 Session 3 [ Time Frame: 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 [ Time Frame: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup ]
Same as current
Not Provided
Not Provided
 
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Drug: ketoconazole
  • Drug: GSK189075
    Other Names:
    • GSK189075
    • ketoconazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
Not Provided
Not Provided

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00501397
KG2108197
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP