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Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects
9 juni 2017 bijgewerkt door: GlaxoSmithKline
An Open-label, Non-randomised, Three-way Crossover, Single Dose Study to Determine the Absolute Bioavailability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder, in Healthy Subjects
This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects.
Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared to the medication administered intravenously (where bioavailability is 100%).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Fluticasone furoate (FF), a novel glucocorticoid, and GW642444, a potent, inhaled longacting, beta2-receptor agonist (LABA), are currently under development in combination for use as a once-daily, inhaled treatment for asthma and chronic obstructive pulmonary disease (COPD).
FF is also being developed as a stand-alone product for asthma and GW642444 is also being developed as a stand-alone product and in combination with a novel, long-acting muscarinic antagonist for the treatment of COPD.
This study is being performed to determine the absolute bioavailability of both FF and GW642444 when delivered in combination from the novel dry powder inhaler.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
16
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
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New South Wales
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Randwick, New South Wales, Australië, 2031
- GSK Investigational Site
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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 64 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Healthy male or female between 18 and 64 years of age inclusive
- Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
- Subjects who are current non-smokers
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
- No significant abnormality on the Holter ECG at screening
- FEV1 ≥ 85% predicted at screening.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
- Subjects who are able to use the inhalation device satisfactorily
Exclusion Criteria:
- As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg
- Any history of breathing problems in adult life
- Pregnant or lactating females
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit
- Subjects with recent history (within 6 months) of pneumonia
- 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
- Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
- History of milk protein allergy
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) 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 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
- The subject has taken oral corticosteroids less than 8 weeks before the screening visit
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
- History of alcohol/drug abuse or dependence within 12 months of the study
- 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)
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- The subject has tested positive for HIV antibodies
- A positive pre-study urine drug screen or when randomly tested during the study
- Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
- Positive urine cotinine test at screening
- Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication
- Unwillingness or inability to follow the procedures outlined in the protocol
- Subject is mentally or legally incapacitated
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: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: Treatment period 1
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1
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Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
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Ander: Treatment Period 2
Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
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Single IV dose of FF (250mcg)
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Ander: Treatment Period 3
Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
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Single IV dose of GW642444 (55mcg)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously
Tijdsspanne: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments
Tijdsspanne: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
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Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability
Tijdsspanne: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability
Tijdsspanne: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability
Tijdsspanne: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Tijdsspanne: Approximately 9 weeks for each subject
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Approximately 9 weeks for each subject
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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)
17 mei 2010
Primaire voltooiing (Werkelijk)
15 juli 2010
Studie voltooiing (Werkelijk)
15 juli 2010
Studieregistratiedata
Eerst ingediend
10 juni 2010
Eerst ingediend dat voldeed aan de QC-criteria
17 februari 2011
Eerst geplaatst (Schatting)
18 februari 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 juni 2017
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2017
Laatst geverifieerd
1 juni 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 102934
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
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Statistisch analyseplan
Informatie-ID: 102934Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: 102934Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Specificatie gegevensset
Informatie-ID: 102934Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Geannoteerd casusrapportformulier
Informatie-ID: 102934Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: 102934Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 102934Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: 102934Informatie 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 .