Last updated: 11/04/2018 10:06:54

A Three-Part Study Of GSK580416 In Healthy Subjects

GSK study ID
OPS106400
Clinicaltrials.gov ID
NCT00427141
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A three-part first time in human study to evaluate safety, tolerability, pharmacokinetics and food effect of single oral doses of GSK580416 in healthy adult subjects
Trial description: Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.

Timeframe: during the study

Secondary outcomes:

Blood samples to determine drug levels in the body will be collected during the study.

Timeframe: during the study

Interventions:
  • Drug: GSK580416
    • Enrollment:
    48
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Respiratory Tract Infection, Infections, Bacterial
    Product
    GSK580416
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to May 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy as determined by a physician
    • Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
    • Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
    • Male and female subjects not willing to follow study specified contraceptive methods
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy as determined by a physician
    • Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
    • Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)
    Exclusion criteria:
    • Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
    • Male and female subjects not willing to follow study specified contraceptive methods
    • Subjects taking any recreational drugs
    • Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
    • Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
    • Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
    • Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
    • Use of St. John's Wort within 28 days before the first dose of study drug
    • Subjects not willing to follow study specified life style restrictions
    • Blood donation in excess of 500 mL within a 56 days period

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, Sydney, New South Wales, Australia, 2031
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-28-05

    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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