A Three-Part Study Of GSK580416 In Healthy Subjects

Phase 1

Completed

• Conditions: Respiratory Tract Infection; Infections, Bacterial

• Registration Number: NCT00427141
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-01-24
• Study First Submitted QC: 2007-01-24
• Study First Posted: 2007-01-26
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Blood samples to determine drug levels in the body will be collected during the study.	during the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Randwick, Sydney, New South Wales, Australia