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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Healthy Subjects

Study type: Observational

Funder types: Industry

Identifiers

NCT00436228

OPB107935

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.