Healthy Subjects, Infections, Bacterial
Conditions
Keywords
Healthy Volunteer
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
Interventions
DRUGGSK945237
DRUGSugar Pill
Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | Day 1 to follow-up visit |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Day 1 to Day 5 |
Countries
Australia
Outcome results
None listed