To Study And Compare Bioavailability And Safety Of Four D... | NCT00436228

Studies
To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug

NCT00436228

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Healthy Subjects

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Nov 2006

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Feb 15, 2007

First Submission Date that Met QC Criteria

Feb 16, 2007

First Posted Date

Feb 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Description Module

Brief Summary

SB-742510 is a semi-synthetic pleuromutilin antibiotic that is being developed for treatment of respiratory infections.

The purpose of this study is to estimate the bioavailability of four different formulations and to evaluate the safety of each of the four formulations

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy as determined by a responsible physician, based on medical evaluations performed at screening.
Healthy adults between 18 and 60 years of age, inclusive.
Body weight proportional to height.
Capable of giving written informed consent.
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 the 12-lead surface electrocardiogram at screening or pre-dose.
The subject has a positive pre-study alcohol/urine drug screen.
History of regular use of tobacco, or nicotine-containing products.
A positive pre-study HIV antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody result within 3 months of screening.
Use of certain prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
An unwillingness to comply with lifestyle and/or dietary restrictions.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials, MD	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Tacoma	Washington	98418	United States