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. Identifier: NCT00439959
Recruitment Status : Terminated
First Posted : February 26, 2007
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

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(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Hepatitis C Drug: GSK625433/placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
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.
Study Start Date : October 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439959

United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00439959     History of Changes
Other Study ID Numbers: HSP108233
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: March 2011

Keywords provided by GlaxoSmithKline:
Hepatitis C,
metabolic probe,

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic