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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517673
• Other study ID #: BTI107248
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2007
• Last updated: March 15, 2012
• Start date: July 2007
• Est. completion date: September 2008

Study information

• Verified date: October 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Bacterial Infections
• Healthy Subjects
• Infections, Bacterial

Intervention

Drug:
• GSK945237

• Sugar Pill
Placebo

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		Day 1 to follow-up visit	No
Secondary	Pharmacokinetics		Day 1 to Day 5	No