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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00517673
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Infections, Bacterial Drug: GSK945237 Drug: Sugar Pill Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official 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
Study Start Date : July 2007
Primary Completion Date : September 2008
Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: GSK945237
Active Study Drug
Drug: GSK945237
Placebo Comparator: Sugar Pill
Drug: Sugar Pill

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: Day 1 to follow-up visit ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Day 1 to Day 5 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517673

Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00517673     History of Changes
Other Study ID Numbers: BTI107248
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: October 2011

Keywords provided by GlaxoSmithKline:
Healthy Volunteer

Additional relevant MeSH terms:
Bacterial Infections