Back to resultsA Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
Primary Purpose
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ketoconazole
GSK189075
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring ketoconazole,, drug interaction,, pharmacokinetics, T2DM,
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3
urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3.
Secondary Outcome Measures
Adverse events: all visits
ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
Labs:followup
Urine: 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501397
Brief Title
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
Official Title
An Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole on the Pharmacokinetics of GSK189075
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
Keywords
ketoconazole,, drug interaction,, pharmacokinetics, T2DM,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ketoconazole
Intervention Type
Drug
Intervention Name(s)
GSK189075
Other Intervention Name(s)
ketoconazole
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
Adverse events: all visits
Time Frame
all visits
Title
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
Title
Labs:followup
Time Frame
followup
Title
Urine: Day 1 Session 1,Days 5-6 Session 3
Time Frame
Day 1 Session 1,Days 5-6 Session 3
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers
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