Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults

Phase 1

Terminated

• Conditions: Hepatitis C, Chronic; Hepatitis C

• Registration Number: NCT00439959
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-02-22
• Study First Submitted QC: 2007-02-22
• Study First Posted: 2007-02-26
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2011-03
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: TERMINATED
• 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: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety parameters: adverse events; telemetry; clinical laboratory values, vital signs, and ECGs. Plasma levels of GSK625433. Change in HCV viral load. Taken throughout the study	17 Days

Secondary Outcome Measures

Name	Time	Method
Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study	17 Days

Trial Locations

Locations (1)

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