Last updated: 11/07/2018 06:25:15

Phase I Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2256098 in Healthy VolunteersFTIH

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GSK study ID
113581
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Clinicaltrials.gov ID
NCT00996671
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 Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Food Effect Following Single Oral Doses of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Healthy Subjects
Trial description: The purpose of this study is to test the safety of a new drug and to look at how the drug is handled by your body. This is the first time the drug will be given to people, the drug has been safely given to animals over many days at higher doses than will be given in the study. The study will be done in healthy men and woman to determine what effects, good or bad, it has on thier health. This study will find out:
If the drug has any side effects after one dose of the drug is given?
How much of the drug gets into the bloodstream, and how long does the body take to get rid of it?
If the drug causes any changes to a substance that is in skin, hair or blood.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

To characterize the safety of single doses of GSK2256098 in adult healthy subjects

Timeframe: within 10-14 days following administration of study drug

To characterize the single dose pharmacokinetics of GSK2256098 in blood and urine in adult healthy subjects

Timeframe: 14 days after administration of study drug

Secondary outcomes:

To examine the dose proportionality of GSK2256098 pharmacokinetic parameters following single dose administration in healthy subjects

Timeframe: 14 days

To explore dose- and concentration-effect relationships for various safety parameters, if appropriate

Timeframe: 14 days

To estimate the effect of high fat/calorie meal on the pharmacokinetics, safety, and tolerability of a single dose of GSK2256098.

Timeframe: 14 days

To explore and potentially identify small molecules or cytokines in plasma which may serve as biomarkers for future studies

Timeframe: 14 days

Interventions:
  • Drug: GSK2256098
  • Drug: Placebo
    • Enrollment:
    38
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cancer
    Product
    GSK2256098
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to March 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    • AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    • AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
    • Urine microalbumin: creatinine ratio < 300 mg/g.
    • Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
    • female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
    • Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until the end of the follow-up period.
    • Body weight greater than or equal to 50 kg and body mass index (BMI) within the range 18.5 to 30.0 kg/m2 (inclusive).
    • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    • Average QTcF < 450 msec (based on averaged results of three ECGs).
    Exclusion criteria:
    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three months of screening.
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    • A positive pre-study drug/alcohol screen.
    • A positive test for HIV antibody.
    • History of alcohol consumption within six months of the study defined as: an average weekly intake of > 21 units for males or > 14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
    • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, five half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
    • Exposure to more than four new chemical entities or investigational products within 12 months prior to the first dosing day.
    • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within seven days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
    • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
    • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    • Pregnant females as determined by positive serum hCG test at screening or positive urine hCG test prior to dosing.
    • Lactating females.
    • Unwillingness or inability to follow the procedures outlined in the protocol.
    • Subject is mentally or legally incapacitated.
    • History of sensitivity to heparin or heparin-induced thrombocytopenia.
    • Subjects who have asthma or a history of asthma or reactive airway disease.
    • History of regular tobacco use or nicotine containing products within three months prior to screening or a positive urine cotinine test result indicative of smoking at screening.
    • Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or kumquats, pummelos, exotic citrus fruit (i.e., star fruit, bitter melon), grapefruit hybrids or fruit juices from seven days prior to the first dose of study medication.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Melbourne, Victoria, Australia, 3004
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-17-03

    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

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    Additional information
    Results for study 113581 can be found on the GSK Clinical Study Register.
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