Status:
COMPLETED
To Study And Compare Bioavailability And Safety Of Four Different Formulations Of The Study Drug
Lead Sponsor:
GlaxoSmithKline
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-60 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00436228
Start Date
November 1 2006
End Date
February 1 2007
Last Update
October 13 2008
Active Locations (1)
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1
GSK Investigational Site
Tacoma, Washington, United States, 98418