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

May 31, 2012 updated by: GlaxoSmithKline

A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK625433 in Healthy Subjects and in Subjects Who Are Chronically Infected With Hepatitis C.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: GSK625433/placebo

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Indiana
  - Evansville, Indiana, United States, 47714
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

Healthy males & females
Part 1 ages 18-60
Part 2 ages 18-50 & 65-80
Within normal weight range given your height
Negative urine drug and alcohol test
Willing to follow all study procedures

Exclusion criteria:

Any significant abnormal lab, ECG, medical or physical exam finding during screening
Allergy to the study drug
Excessive alcohol intake
Positive HIV or hepatitis B or C result
Use of prescription or non-prescription drugs within one week of study start except for birth control
Blood pressure meds & Tylenol
Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 17 Days	17 Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria