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OpenTrials
Completed

NCT Number: NCT00436228

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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-Label, Randomized, Crossover Study to Estimate the Formulation Effect on the Relative Bioavailability of Single Dose Oral SB-742510 in Healthy Subjects

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 19, 2007
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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