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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436228
• Other study ID #: OPB107935
• Status: Completed
• Phase: N/A
• First received: February 15, 2007
• Last updated: October 9, 2008
• Start date: November 2006
• Est. completion date: February 2007

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
United States	GSK Investigational Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States,