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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00436228

Enrollment

Registered

2007-02-19

Start date

2006-11-30

Completion date

2007-02-28

Last updated

2008-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

healthy volunteer,, Bioavailability,, safety, Phase I,

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 formulations and to evaluate the safety of each of the four formulations

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Countries

United States

Outcome results