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

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

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Healthy Subjects

Keywords

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healthy volunteer, Bioavailability, safety Phase I,

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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OPB107935

Identifier Type: -

Identifier Source: org_study_id