A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects

PHASE1TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 7, 2013

Primary Completion Date

October 18, 2013

Study Completion Date

October 18, 2013

Conditions
Infections, Bacterial
Interventions
DRUG

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

DRUG

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

DRUG

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

DRUG

Placebo tablets

Light beige, oval-shaped, film-coated tablet for repeat dose oral administration (BID for 6 days) in Part C

DRUG

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

DRUG

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

DRUG

Placebo injection

A clear and colorless 0.9% Sodium Chloride solution for intravenous administration twice daily for 4 days in Part C

Trial Locations (1)

66211

GSK Investigational Site, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01818011 - A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects | Biotech Hunter | Biotech Hunter