GW679769 may affect liver enzymes that metabolize dexamethasone and ondansetron. This study is designed to test the safety and the extent of the GW679769 affect on dexamethasone and ondansetron levels in humans.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
37
Casopitant (GW679769) tablets will be available as white, film-coated tablets containing 50 mg of GW679769 as the mesylate salt for oral administration.
Dexamethasone will be available as 4 mg tablets for oral administration and injection for IV administration.
Ondansetron for oral use will be available as 8 mg tablets to be taken with 240 milliliters (mL) of water on an empty stomach. For IV use, ondansetron 32 mg will be infused intravenously over a period of 15 minutes.
GSK Investigational Site
Buffalo, New York, United States
Part A: Period 1 & 2: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3. Part B: Period 1, 2 & 3: Plasma levels of casopitant, dexamethasone, & ondansetron will be checked on Day 1, 2 and/or 3.
Time frame: checked on Day 1, 2 and/or 3
Safety is evaluated by: Clinical Lab Tests done
Time frame: at Screening, Day -1 & Followup.
Vitals Signs taken & Adverse Events monitored
Time frame: at each visit starting at Day -1.
12 lead ECGs & Serum Pepsinogen level tests
Time frame: at Screening & Followup.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.