Last updated: 11/04/2018 08:14:43

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

GSK study ID
HSP108233
Clinicaltrials.gov ID
NCT00439959
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

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

Timeframe: 17 Days

Secondary outcomes:

Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study

Timeframe: 17 Days

Interventions:
  • Drug: GSK625433/placebo
    • Enrollment:
    48
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis C, Chronic
    Product
    GSK625433
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to March 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy males & females
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-23-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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