This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled, dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy subjects. Study will be conducted in four periods; subjects will receive either placebo or GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period. Each period will be separated by washout period (at least 6 days from dosing). Total duration of study for each subject will be approximately 5 weeks from the first dosing to follow up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672.
It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672
GSK Investigational Site
Tokyo, Japan
Number of Subjects with Adverse events (AE)
Time frame: Maximum of 5 weeks
Safety as assessed by blood pressure
Systolic and diastolic blood pressure will be measured on Day -1, post dose 2 hours (hrs), 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Safety as assessed by heart rate
Heart rate will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Safety as assessed by body temperature
Body temperature will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Safety as assessed by clinical chemistry parameters
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Time frame: Maximum of 5 weeks
Safety as assessed by haematology
Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Time frame: Maximum of 5 weeks
Safety as assessed by urinalysis
Sample will be collected on Day -1, at 48 hrs in each period and at follow-up
Time frame: Maximum of 5 weeks
Safety as assessed by fecal occult blood
Fecal occult blood testing will be conducted on Screening (2 samples during Screening period) and each dosing period (anytime from dosing to next dose).
Time frame: Maximum of 5 weeks
Safety as assessed by Electrocardiogram (ECG)
Electrocardiogram will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
Time frame: Maximum of 5 weeks
Plasma concentration of GSK2330672
Time frame: Blood samples will be collected predose and post dose at 0.5 hrs, 2 hr, 3.5 hr, 5 hr on Day 1 of each period
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