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

Phase 1TerminatedNCT00439959

GlaxoSmithKline48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C, Chronic Hepatitis C

Interventions

GSK625433/placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.