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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C, Chronic, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00439959

Run by

GlaxoSmithKline

People needed

48

Starts

2006-10-01

Expected to finish

2007-03-01

Last updated by the study team

2012-06-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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