12
Participants
Start Date
August 7, 2013
Primary Completion Date
October 18, 2013
Study Completion Date
October 18, 2013
GSK1322322 Initial fit for purpose tablets
Beige, capsule shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1500 mg (3 x 500 mg) for single dose oral administration in Part A
GSK1322322 over granulated tablets
Light beige, oval shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1500 mg (3 x 500 mg) for single dose oral administration in Part A
GSK1322322 intended commercial tablets
Light beige, oval shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1000 mg (2 x 500),1500 mg (3 x 500 mg) and 2000 mg (4 x 500mg) for single dose oral administration in Part A and B and repeat dose administration twice daily in Part C
Placebo tablets
Light beige, oval-shaped, film-coated tablet for repeat dose oral administration (BID for 6 days) in Part C
13C-GSK1322322 stable isotope powder
White to slightly colored non-sterile crystalline powder for oral suspension with dose level of 50 mg as a single dose with GSK1322322 tablets in Part A
GSK1322322 for injection
White to slightly colored lyophilized powder cake in clear glass vials with unit dose strength of 400 mg/vial and dose levels of 600 mg (1.5 x 400 mg/vial), 900 mg (2.25x400mg/vial), 1200 mg (3x400mg/vial and 1200 mg (3 x 400 mg) for IV administration either as single dose in Part B or as a repeat dose (BID for 4 days) in Part C
Placebo injection
A clear and colorless 0.9% Sodium Chloride solution for intravenous administration twice daily for 4 days in Part C
GSK Investigational Site, Overland Park
Lead Sponsor
GlaxoSmithKline
INDUSTRY