Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus
Conditions
Keywords
Dose Escalation;, Supratherapeutic;, GSK189075;, Diabetes
Brief summary
This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.
Interventions
DRUGGSK189075
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests. * written consent given * agreement to follow specific requirements of birth control during participation.
Exclusion criteria
* history of drug or alcohol abuse within one year of the study screening. * use of tobacco or nicotine-containing products with 6 months prior to the study screening. * use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study. * blood donation within 56 days before the start of the study * receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical laboratory tests, ECGs, adverse events | screening, Day -1 - 3 all periods, follow up |
Secondary
| Measure | Time frame |
|---|---|
| blood plasma levels of GSK189075 | Day 3 |
| clinical lab tests | each day |
Countries
United States
Outcome results
None listed