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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Subjects Infections, Bacterial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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GSK945237

Active Study Drug

Group Type EXPERIMENTAL

GSK945237

Intervention Type DRUG

Sugar Pill

Placebo

Group Type PLACEBO_COMPARATOR

Sugar Pill

Intervention Type DRUG

Placebo

Interventions

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GSK945237

Intervention Type DRUG

Sugar Pill

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes