A Three-Part Study Of GSK580416 In Healthy Subjects

NCT00427141 | Completed Phase 1

• 1 other identifier: OPS106400
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Infection; Infections, Bacterial

Keywords

tolerability,; pharmacokinetics,; first time in human,; food effect; safety,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood samples to determine drug levels in the body will be collected during the study.

  during the study

Interventions

GSK580416 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 26, 2007
• Study Start: October 1, 2006
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

AU (1)