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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00517673
First received: August 15, 2007
Last updated: March 15, 2012
Last verified: October 2011

August 15, 2007
March 15, 2012
July 2007
September 2008   (final data collection date for primary outcome measure)
Safety and tolerability [ Time Frame: Day 1 to follow-up visit ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00517673 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Day 1 to Day 5 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
  • Healthy Subjects
  • Infections, Bacterial
  • Drug: GSK945237
    Other Name: GSK945237
  • Drug: Sugar Pill
    Placebo
  • Experimental: GSK945237
    Active Study Drug
    Intervention: Drug: GSK945237
  • Placebo Comparator: Sugar Pill
    Placebo
    Intervention: Drug: Sugar Pill
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00517673
BTI107248
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP