GSK1349572 First Time in Human Study

Phase 1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00555035
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To determine safety, tolerability and pharmacokinetics of GSK1349572

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-07
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2010-10
• Disposition First Submitted: 2010-10-13
• Disposition First Submitted QC: 2010-10-13
• Last Update Submitted: 2010-10-13
• Disposition First Posted: 2010-10-15
• Last Update Posted: 2010-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood levels of drug over 72 hours. Laboratory test results over 72 hours Vital signs, ECG results over 72 hours	72 hours.

Secondary Outcome Measures

Name	Time	Method
GSK1349572 PK parameters: absorption lag time (tlag), and apparent clearance (CL/F) following single dose administration.
AUC(0-¥), AUC(0-t), Cmax, and C24 following single dose administration at different doses for the assessment of dose proportionality.
Dose proportionality over 72 hours	72 hours.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Evansville, Indiana, United States