A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2012

Conditions
Infections, Bacterial
Interventions
DRUG

GSK1322322 (mesylate salt) Powder for Injection

1500 mg (mesylate salt) as free base, dissolved in sterile water for injection to a concentration of 100 mg/mL free base equivalent and sterilized via filtration. 15 mL of solution, equivalent to 1500 mg GSK 1322322, is the diluted into 0.9% Sodium Chloride Injection prior to infusion

DRUG

GSK1322322 (freebase) tablets

500 mg tablets for a 1500 mg total single dose (3 tablets). Taken with 240 mL of water

DRUG

GSK1322322 (mesylate salt) Powder for Oral Solution

1500 mg as a free base, dissolved in purified water to a concentration of 100 mg/mL free base equivalent. 15 mL of solution, equivalent to1500 mg GSK1322322 is administered orally with 225 mL of water

DRUG

GSK1322322 (freebase) tablets FED

Drug 500 mg tablets for a 1500 mg total single dose (3 tablets) (FED moderate fat meal) Taken with 240 mL of water

Trial Locations (1)

55404

GSK Investigational Site, Minneapolis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01648179 - A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects | Biotech Hunter | Biotech Hunter