To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects; Infections, Bacterial
• Interventions: Drug: GSK945237; Drug: Sugar Pill

• Registration Number: NCT00517673
• Lead Sponsor: GlaxoSmithKline

Brief Summary

GSK945237 is the first molecule of a new chemical class that is being developed for treatment of respiratory tract and other infections such as skin and soft tissue. This study drug has been tested in animals but has never been given to humans. This is a two part study. The purpose of the first part is to study the side effects of this drug in humans, and to study how much of the drug gets absorbed in the blood stream The second part of this study will compare absorption of the study drug in the blood stream when given with food and when given under fasting conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-15
• Study First Submitted QC: 2007-08-15
• Study First Posted: 2007-08-17
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-10
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Healthy male and female adults between 18 and 60 years of age.
• Body weight proportional to height.
• Female subjects must be of non-childbearing potential.
• QTc less than 450 msec at screening

Exclusion Criteria

• Any clinically relevant abnormality identified on the screening history and physical, or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or pre-dose.
• A positive pre-study alcohol/urine drug screen.
• Use of nicotine-containing products.
• A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result.
• Recent participation in another study, use of certain medications, consumption certain fruits, juices, or red wine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK945237	GSK945237	Active Study Drug
Sugar Pill	Sugar Pill	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	Day 1 to follow-up visit

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	Day 1 to Day 5

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Adelaide, South Australia, Australia