Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: GSK625433/placebo	Phase I

MedlinePlus related topics:

Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Single Group Assignment, Pharmacokinetics/Dynamics Study

Official Title:	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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Enrollment:	48
Study Start Date:	October 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439959

Locations


United States, Indiana
	GSK Investigational Site
	Evansville, Indiana, United States, 47714

United States, Minnesota
	GSK Investigational Site
	Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	HSP108233
First Received:	February 22, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00439959
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Hepatitis C,

HCV,

polymerase,

GSK625433,

metabolic probe,

food-effect,

FTIH

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis, Viral, Human

Healthy

Hepatitis C

Additional relevant MeSH terms:

RNA Virus Infections

Flaviviridae Infections

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00439959