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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00436228
First received: February 15, 2007
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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


Condition
Healthy Subjects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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

Further study details as provided by GlaxoSmithKline:

Enrollment: 32
Study Start Date: November 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436228

Locations
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00436228     History of Changes
Other Study ID Numbers: OPB107935
Study First Received: February 15, 2007
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
healthy volunteer,
Bioavailability,
safety
Phase I,

ClinicalTrials.gov processed this record on April 22, 2014