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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00439959
First received: February 22, 2007
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  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, Chronic
Hepatitis C
 Drug: GSK625433/placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

U.S. FDA Resources

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)
Intervention Details:
    Drug: GSK625433/placebo
    Other Name: GSK625433/placebo
  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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00439959     History of Changes
Other Study ID Numbers: HSP108233
Study First Received: February 22, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK625433,
Hepatitis C,
metabolic probe,
food-effect,
 HCV,
FTIH
polymerase,

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on May 23, 2013