Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
Resource links provided by the National Library of Medicine
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 Outcome Measures
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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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