Status:
TERMINATED
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00439959
Start Date
October 1 2006
End Date
March 1 2007
Last Update
June 4 2012
Active Locations (1)
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1
GSK Investigational Site
Evansville, Indiana, United States, 47714