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

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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