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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Infections, Bacterial

Healthy Subjects

Treatments

Drug: GSK945237

Drug: Sugar Pill

Study type

Interventional

Funder types

Industry

Identifiers

NCT00517673

BTI107248

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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