NCT01615796

Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses

A Two-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses of GSK2140944 in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials.

Detailed description

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft issue infections including isolates resistant to existing classes of antimicrobials. This study will be the first administration of GSK2140944 as an intravenous (IV) formulation in humans and will be conducted in two (2) parts. Single IV doses will be explored in Part A and repeat IV doses will be explored in Part B. In addition, this study will evaluate the absolute bioavailability of an oral capsule formulation as compared to the IV formulation in Part A. Both study parts will investigate the safety, tolerability and pharmacokinetic profile of GSK2140944 in healthy adult subjects.

Conditions

• Infections, Respiratory Tract

Interventions

Type	Name	Description
DRUG	Part A: GSK2140944 Drug single dose of 200mg, 600mg, 1200mg, 1800 mg, and dose to be determined	Subjects receive a single dose of GSK2140944
DRUG	Part B: GSK2140944 Repeat Drug dose of 400mg, 750mg, 1000 mg, and dose to be determined	Subjects will receive repeat doses of GSK2140944 BID/TID for up to 14 Days

Timeline

• Start date: 2012-06-04
• Primary completion: 2014-02-21
• Completion: 2014-02-21
• First posted: 2012-06-11
• Last updated: 2017-05-09

Locations

1 site across 1 country: Australia