Last updated: 11/04/2018 08:32:30
A study to compare the safety and drug levels in blood when using various forms of GSK189075 given to healthy subjects
GSK study ID
KGW111057
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label, randomized, single dose, crossover study to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of modified release formulations of GSK189075 in healthy volunteers
Trial description: The purpose of this research study is to look at concentrations of GSK189075 in blood when different long and short acting forms of the drug are taken by mouth. The results will help to decide whether a long-acting form of GSK189075 can be made. The effects of the drug on the body and safety will also be studied.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Blood samples:
Timeframe: collected over 24-hour period after each different form of GSK189075 given to measure amount of drug in blood
Urine:
Timeframe: collected over 24-hour period after dosing with each form to measure amount of urine produced & amount of sugar in urine
Secondary outcomes:
Adverse events:
Timeframe: all visits after Day -1
blood pressure & heart rate:
Timeframe: screening,Day -1 - Day 1,follow-up visit
ECGs:
Timeframe: screening,pre-dose, Day 1
lab tests:
Timeframe: screening, Day -1 - Day 1,follow-up
Interventions:
Drug: GSK189075 (Modified and immediate release formulations)
Enrollment:
36
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)
November 2007 to December 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Are a healthy, non-smoking adult, 18 to 55 years old.
- Are not overly thin or overly heavy for your height.
- Are a pregnant or a nursing female.
- Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
Inclusion and exclusion criteria
Inclusion criteria:
- Are a healthy, non-smoking adult, 18 to 55 years old.
- Are not overly thin or overly heavy for your height.
- Are a female who is unable to have children, or is willing to use birth control throughout the study.
- Are willing and able to follow all study-related instructions provided by the site staff.
- Are willing to provide signed consent.
Exclusion criteria:
- Are a pregnant or a nursing female.
- Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
- Have had certain infections within 4 weeks before the expected the first dose of study drug.
- Have HIV or hepatitis, or have alcohol in your system at the screening visit.
- Have a history of alcohol abuse.
- Have been in another research study in the last month or have taken certain medications in the 2 weeks before study drug would be taken.
- Have laboratory tests that are outside the normal range.
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
2007-20-12
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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