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A First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single & Repeat Escalating Doses of GSK2878175 in Healthy Subjects

Hepatitis C, Chronic Clinical Trial

Official title:
A Randomized, Single-Blind, Dose Escalation, First Time in Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of GSK2878175 in Healthy Adults

Clinical Trial Summary

GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment of chronic HCV infection. This study represents the first administration of GSK2878175 in humans to define safety, tolerability, and pharmacokinetics (PK) following single and repeat doses of GSK2878175 in healthy subjects.

This is a Phase 1, randomized, single-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, and PK profile of GSK2878175 in single (Part 1) and repeat doses (Part 2) in healthy subjects. In addition the study will explore the effect of a moderate (30%) fat meal on single dose PK endpoints in healthy subjects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01879462
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date June 14, 2013
Completion date January 10, 2014
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