MedTrace Logo

Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections

NCT02045797 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-11-17

Study results available
· View outcomes & findings →

Summary

GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study designed to select the optimal dose by further characterizing the safety, tolerability and PK of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure infections (ABSSSI). The selected dose will be used in future studies.

Conditions

  • Infections, Bacterial

Interventions

DRUG

GSK2140944 Lyophile

GSK2140944 Lyophile (pale yellow to grayish yellow cake) containing 750 mg of GSK2140944 (as free base) per vial for IV infusion.

DRUG

GSK2140944 Capsules

GSK2140944 500 mg capsules will be supplied as pink hard gelatin capsule with no external markings filled with slightly agglomerated pale yellow to grayish yellow powder.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-24
Primary Completion
2015-06-29
Completion
2015-06-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02045797 on ClinicalTrials.gov