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A First Time in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Single and Repeat Doses of GSK2485852 in Chronically Infected Hepatitis C Subjects

NCT01332552 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-07-07

No results posted yet for this study

Summary

GSK2485852 is a Hepatitis C NS5B site IV non-nucleoside polymerase inhibitor being developed for the treatment of chronic HCV infection. HBI115040 is the first administration of GSK2485852 in humans to establish the initial safety, tolerability, pharmacokinetic, and antiviral profile. The study design is a fusion of single and repeat dosing cohorts in HCV infected subjects to evaluate the safety, pharmacokinetics, and antiviral activity of GSK2485852.

HBI115040 describes a Phase I, randomized, double-blind, placebo-controlled, dose escalation fusion study to determine the safety, tolerability, pharmacokinetic, and antiviral profile of GSK2485852 in single doses (Part 1), repeat doses (Part 2), and ritonavir co-administration (Part 3) in chronically infected HCV subjects. The study will also explore the effect of a moderate (30%) fat meal on pharmacokinetic endpoints in HCV subjects in Part 1.

Conditions

  • Hepatitis C

Interventions

DRUG

GSK2485852 70 mg

single dose

DRUG

GSK2485852 420 mg

single dose

DRUG

placebo

single dose

DRUG

placebo

Repeat dose, once daily for 3 days

DRUG

GSK2485852 420 mg

Repeat dose, twice daily for 3 days

DRUG

GSK2485852 420 mg

Repeat dose, TIDfor 3 days

DRUG

GSK2485852 630 mg

Repeat dose, twice daily for 3 days

DRUG

GSK2485852 70 mg + Ritonavir 100mg

single dose, day 1

DRUG

GSK2485852 210 mg + Ritonavir 100mg

single dose, day 1

DRUG

GSK2485852 210 mg +Ritonavir 100mg

single dose daily for 3 days

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-14
Primary Completion
2011-04-06
Completion
2011-04-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01332552 on ClinicalTrials.gov