Relative Bioavailability Study in Healthy Subjects

Summary

Part 1 of this study will assess the relative bioavailability of GSK1322322 administered as one of three investigational tablets compared to powder in a bottle formulation. Pharmacokinetics of these three tablets will be evaluated and the investigation tablet with the optimal PK profile will be progressed to Part 2. In Part 2 the investigational tablet selected from Part 1 will be coadministered with food alone, an H2 blocker alone, or an H2 blocker given in combination with ascorbic acid to evaluate the effect on GSK1322322 pharmacokinetics. Plasma GSK1322322 PK profile, safety, and tolerability will be assessed from each dose group.

Timeline

Start

2009-04-27

Primary completion

2009-07-09

Completion

2009-07-09

Publications

• Background Naderer OJ, Dumont E, Zhu J, Kurtinecz M, Jones LS. Effect of H2 blockade and food on single-dose pharmacokinetics of GSK1322322, a peptide deformylase inhibitor antibacterial. Antimicrob Agents Chemother. 2013 Jun;57(6):2556-61. doi: 10.1128/AAC.02505-12. Epub 2013 Mar 25.

Drugs

Indications