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Relative Bioavailability Study for GSK1278863A

22. Juni 2017 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Texas
      • Austin, Texas, Vereinigte Staaten, 78744
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Experimental: 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
Experimental: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Area under plasma concentration-time curve (AUC (0-inf)) and maximum plasma concentration (Cmax) of GSK1278863A.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cmax, AUC (0-t), AUC(0-infinite), tmax, and t1/2 (as data permit) of GSK1278863A metabolites.
Zeitfenster: 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.
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

25. Februar 2011

Primärer Abschluss (Tatsächlich)

18. April 2011

Studienabschluss (Tatsächlich)

18. April 2011

Studienanmeldedaten

Zuerst eingereicht

17. März 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. März 2011

Zuerst gepostet (Schätzen)

21. März 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juni 2017

Zuletzt verifiziert

1. Juni 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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

Studiendaten/Dokumente

  1. Klinischer Studienbericht
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Einwilligungserklärung
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Kommentiertes Fallberichtsformular
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistischer Analyseplan
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datensatzspezifikation
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studienprotokoll
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Einzelner Teilnehmerdatensatz
    Informationskennung: 114703
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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