NCT01648179

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

A Single Dose, Open Label, Randomized, Balanced, Crossover Study to Assess the Relative Bioavailability of ThreeFormulations and Food Effect on GSK1322322 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.

Detailed description

This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects: * The relative bioavailability of the wet milled GSK1322322 tablet formulation with and without food compared to an oral mesylate salt solution. * The effect of body weight on the pharmacokinetics of GSK1322322 when given either orally or IV. * The absolute bioavailability of the wet milled tablet and the oral mesylate salt solution compared to the IV formulation.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-07-24
• Last updated: 2017-03-22

Locations

1 site across 1 country: United States