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
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website