NCT01879462

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	GSK2878175	Round tablets (5.0mg) given once daily single and repeated (to 7 days), Oral dose.
DRUG	Placebo	Visually matching GSK2878175

Timeline

• Start date: 2013-06-14
• Primary completion: 2014-01-10
• Completion: 2014-01-10
• First posted: 2013-06-17
• Last updated: 2018-07-24

Locations

1 site across 1 country: Australia