- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01299558
Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects
9 giugno 2017 aggiornato da: 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%).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
16
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- GSK Investigational Site
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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
|
Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
|
|
Altro: Treatment Period 2
Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2
|
Single IV dose of FF (250mcg)
|
|
Altro: Treatment Period 3
Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3
|
Single IV dose of GW642444 (55mcg)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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
Lasso di tempo: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
|
Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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
Lasso di tempo: Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
|
Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks
|
|
Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability
Lasso di tempo: Approximately 9 weeks for each subject
|
Approximately 9 weeks for each subject
|
|
Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability
Lasso di tempo: Approximately 9 weeks for each subject
|
Approximately 9 weeks for each subject
|
|
Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability
Lasso di tempo: Approximately 9 weeks for each subject
|
Approximately 9 weeks for each subject
|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Lasso di tempo: Approximately 9 weeks for each subject
|
Approximately 9 weeks for each subject
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 maggio 2010
Completamento primario (Effettivo)
15 luglio 2010
Completamento dello studio (Effettivo)
15 luglio 2010
Date di iscrizione allo studio
Primo inviato
10 giugno 2010
Primo inviato che soddisfa i criteri di controllo qualità
17 febbraio 2011
Primo Inserito (Stima)
18 febbraio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 giugno 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 giugno 2017
Ultimo verificato
1 giugno 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 102934
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dati/documenti di studio
-
Piano di analisi statistica
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Set di dati del singolo partecipante
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Specifica del set di dati
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di segnalazione del caso annotato
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Modulo di consenso informato
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Rapporto di studio clinico
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
-
Protocollo di studio
Identificatore informazioni: 102934Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su fluticasone furoate//GW642444
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaStati Uniti, Argentina, Estonia, Canada, Chile, Germania, Perù, Filippine, Messico, Corea, Repubblica di, Danimarca, Federazione Russa, Polonia, Slovacchia
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaRegno Unito
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaSvezia, Norvegia
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaGiappone
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaSud Africa, Stati Uniti, Canada, Ucraina, Regno Unito, Danimarca, Cechia
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaAustralia, Nuova Zelanda
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaGiappone
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaRegno Unito
-
GlaxoSmithKlineCompletatoMalattia polmonare, cronica ostruttivaRegno Unito
-
Queen's UniversityGlaxoSmithKlineCompletato