A Three-Part Study Of GSK580416 In Healthy Subjects

A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Infections, Bacterial; Respiratory Tract Infection
• Intervention / Treatment: Drug: GSK580416

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, Sydney, New South Wales, Australia, 2031
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Healthy as determined by a physician
• Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
• Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)

Exclusion criteria:

• Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
• Male and female subjects not willing to follow study specified contraceptive methods
• Subjects taking any recreational drugs
• Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
• Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
• Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
• Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
• Use of St. John's Wort within 28 days before the first dose of study drug
• Subjects not willing to follow study specified life style restrictions
• Blood donation in excess of 500 mL within a 56 days period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.	during the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood samples to determine drug levels in the body will be collected during the study.	during the study

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 2006

Study Registration Dates

• First Submitted: January 24, 2007
• First Submitted That Met QC Criteria: January 24, 2007
• First Posted (Estimate): January 26, 2007

Study Record Updates

• Last Update Posted (Estimate): June 4, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: food effect; safety,; pharmacokinetics,; tolerability,; first time in human,
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Respiratory Tract Infections; Bacterial Infections
• Other Study ID Numbers: OPS106400