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OpenTrials
Completed

NCT Number: NCT00517673

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

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

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Key information

Conditions

Healthy Subjects Bacterial Infections Bacterial Infections and Mycoses Infections Infections, Bacterial

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK945237

Drug

Sugar pill

Drug

Placebo

Primary outcomes

  1. Safety and tolerability

    Time frame: Day 1 to follow-up visit

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Day 1 to Day 5

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Two-Part Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK945237 and the Effect of Food on Single Oral Doses of GSK945237 in Healthy Adult Subjects

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 17, 2007
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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