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Relative Bioavailability Study for GSK1278863A

22 juni 2017 bijgewerkt door: GlaxoSmithKline

A Randomized, Open-label, 3-period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of Single Oral 100mg Doses of GSK1278863A

A randomized, open-label, 3-period crossover study.

Studie Overzicht

Gedetailleerde beschrijving

A randomized, open label, 3-period crossover study in healthy subjects. The primary objective of this study is to determine the relative bioavailability of GSK1278863A after single oral doses of 100mg GSK1278863A tablets with particle sizes of 13, 29, or 41 micrometers (um) in healthy subjects.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Texas
      • Austin, Texas, Verenigde Staten, 78744
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • AST, ALT, alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • 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.
  • Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
  • A 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.
  • Male subjects with female partners of child-bearing potential must agree to use contraception methods
  • Body weight >=50kg and BMI within the range 19 to 29.9kg/m2 (inclusive).
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
  • Subjects must have a normal resting blood pressure, after having rested quietly in a supine position for at least 15 minutes, defined as: >=100mm Hg systolic/60mm Hg diastolic and <=140mm Hg systolic/90mm Hg diastolic.

Exclusion Criteria:

  • Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12 lead) judged by the Investigator and /or medical monitor to potentially introduce additional risk factors and/or interfere with the study procedures.
  • Significant cardiac, pulmonary, metabolic, renal, hepatic, neurological, psychiatric, or gastrointestinal conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial.
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 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.
  • CPK above the normal range.
  • Calculated creatinine clearance: <80mL/min.
  • Subjects with a pre-exisisting condition interfering with normal gastrointestinal anatomy or motility, and/or hepatic function-that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 drinks for males or >14 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled 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, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • History of peptic ulcer disease or of chronic rectal bleeding.
  • History of malignancy. Non-melanoma skin cancer that has been definitively removed is allowed.
  • Subjects with a baseline medical history of proliferative diabetic retinopathy, preproliferative diabetic retinopathy, or wet age-related macular degeneration (AMD).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  • History of sensitivity to any of the investigational products, 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 or urine hCG test at screening or prior to dosing.
  • Lactating females.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • History or sensitivity to heparin or heparin-induced thrombocytopenia.
  • Urinary cotinine levels indicative of smoking. History or regular use of tobacco or nicotine-containing products within 6 months prior to screening.
  • Consumption of >3 servings per day of red wine, grapefruit (juice), blood orange (juice), star fruit, onions, kale, broccoli, green beans, or apples from 7 days prior to the first dose of investigational product, unless in the opinion of the Investigator and GSK Medical Monitor this will not interfere with the study procedures and compromise subject safety.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GSK1278863A 100mg (X90=13um)
single dose
100mg (x90=13um), oral tablet, single-dose with 7 day wash-out
100mg (x90=29um), oral tablet, single-dose with 7 day wash-out
100mg (x90=41um), oral tablet, single-dose with 7 day wash-out
Experimenteel: GSK1278863A 100mg (x90=29Um)
single dose
100mg (x90=13um), oral tablet, single-dose with 7 day wash-out
100mg (x90=29um), oral tablet, single-dose with 7 day wash-out
100mg (x90=41um), oral tablet, single-dose with 7 day wash-out
Experimenteel: GSK1278863 100mg (X90=41um)
single dose
100mg (x90=13um), oral tablet, single-dose with 7 day wash-out
100mg (x90=29um), oral tablet, single-dose with 7 day wash-out
100mg (x90=41um), oral tablet, single-dose with 7 day wash-out

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area under plasma concentration-time curve (AUC (0-inf)) and maximum plasma concentration (Cmax) of GSK1278863A.
Tijdsspanne: pre-dose to 24 hours post-dose
To determine the relative bioavailability of GSK1278863A after single oral doses of 100 mg GSK1278863A tablets with particle sizes of 13, 29 and 41um in healthy subjects.
pre-dose to 24 hours post-dose

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cmax, AUC (0-t), AUC(0-infinite), tmax, and t1/2 (as data permit) of GSK1278863A metabolites.
Tijdsspanne: pre-dose to 24 hours post-dose
To determine the relative exposures of metabolites of GSK1278863A after single oral doses of 100 mg GSK1278863A tablets with particle sizes of 13, 29 and 41um in healthy subjects.
pre-dose to 24 hours post-dose
Safety and tolerability of investigational product as assessed by clinical monitoring of vital signs (blood pressure, pulse rate), ECGs, and laboratory data, as well as reporting of adverse events.
Tijdsspanne: Duration of subject study participation
To assess the safety and tolerability of GSK1278863A after single oral doses of 100 mg GSK1278863A tablets with particle sizes of 13, 29 and 41um in healthy subjects.
Duration of subject study participation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 februari 2011

Primaire voltooiing (Werkelijk)

18 april 2011

Studie voltooiing (Werkelijk)

18 april 2011

Studieregistratiedata

Eerst ingediend

17 maart 2011

Eerst ingediend dat voldeed aan de QC-criteria

17 maart 2011

Eerst geplaatst (Schatting)

21 maart 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2017

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2017

Laatst geverifieerd

1 juni 2017

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Bestudeer gegevens/documenten

  1. Klinisch onderzoeksrapport
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formulier geïnformeerde toestemming
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Geannoteerd casusrapportformulier
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisch analyseplan
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specificatie gegevensset
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Leerprotocool
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Gegevensset individuele deelnemers
    Informatie-ID: 114703
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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