NCT00517673

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 19, 2012

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

August 15, 2007

Last Update Submit

March 15, 2012

Conditions

Healthy SubjectsInfections, Bacterial

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Day 1 to follow-up visit

Secondary Outcomes (1)

  • Pharmacokinetics

    Day 1 to Day 5

Study Arms (2)

GSK945237

EXPERIMENTAL

Active Study Drug

Drug: GSK945237

Sugar Pill

PLACEBO COMPARATOR

Placebo

Drug: Sugar Pill

Interventions

GSK945237DRUG
GSK945237
Sugar PillDRUG

Placebo

Sugar Pill

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

GSK945237Sugars

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 17, 2007

Study Start

July 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 19, 2012

Record last verified: 2011-10

Locations

AU(1)