A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
22 gennaio 2016 aggiornato da: Pfizer
A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.
This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
22
Fase
- Fase 2
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
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Berlin, Germania, 10117
- Pfizer Investigational Site
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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 40 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
- Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months
Exclusion Criteria:
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
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: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: Placebo
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oral inhaled formulation, single dose
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Comparatore attivo: comparatore attivo
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oral inhaled formulation, single dose
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Sperimentale: PF-03635659
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oral inhaled formulation, single dose, low dose
oral inhaled formulation, single dose, mid dose
oral inhaled formulation, single dose, high dose
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
Lasso di tempo: Baseline, 24, 24.5 hrs post-dose
|
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Trough FEV1 was calculated as the average of the largest FEV1 value from 3 readings recorded at 24 hours (hrs) and 24.5 hrs post-dose.
Baseline FEV1 value was calculated as average of 2 largest pre-dose readings on Day 1 for each period.
Change from baseline in trough FEV1 was the difference between trough FEV1 and baseline FEV1.
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Baseline, 24, 24.5 hrs post-dose
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Maximum Observed Plasma Concentration (Cmax)
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Maximum Observed Plasma Concentration
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Cmax was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
AUClast was normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞).
It was obtained from AUC (0 - t) plus AUC (t-∞).
AUC (0-∞) was dose normalized to a 1 mcg fine particle dose (40, 128 and 320 mcg for the nominal doses of 180, 580 and 1450 mcg respectively).
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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Plasma Decay Half-Life (t1/2)
Lasso di tempo: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (FEV1)
Lasso di tempo: Baseline up to 48 hrs post-dose
|
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Peak FEV1 was defined as change from baseline in maximum FEV1.
Maximum FEV1 = maximum forced expiratory volume in 1 second, recorded between 0.5 hrs to 48 hrs post-dose.
Baseline FEV1 value was calculated as average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 48 hrs post-dose
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Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response
Lasso di tempo: Baseline up to 24.5 hrs post-dose
|
FEV1 was the mean volume of air that can be forced out in 1 second after taking a deep breath.
Weighted average FEV1 was defined as the average area under the effect curve (AUEC) change from baseline FEV1 (the area under the FEV1 effect curve over 24.5 hrs post-dose for each study period corrected for the pre-dose baseline value) divided by 24.5.
Baseline FEV1 value was calculated as the average of two largest pre-dose readings on Day 1 for each period.
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Baseline up to 24.5 hrs post-dose
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Change From Baseline in Force Vital Capacity (FVC)
Lasso di tempo: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
|
FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible.
Baseline FVC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in FVC was the difference between FVC and baseline FVC.
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Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs post-dose
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Change From Baseline in Inspiratory Capacity (IC)
Lasso di tempo: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
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IC was the maximum volume of air that can be inhaled in to the lungs after breathing out normally.
Baseline IC value was calculated as average of two largest pre-dose readings on Day 1 for each period.
Change from baseline in IC was the difference between IC and baseline IC.
|
Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Collegamenti utili
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
1 gennaio 2010
Completamento primario (Effettivo)
1 giugno 2010
Completamento dello studio (Effettivo)
1 giugno 2010
Date di iscrizione allo studio
Primo inviato
15 dicembre 2009
Primo inviato che soddisfa i criteri di controllo qualità
15 dicembre 2009
Primo Inserito (Stima)
16 dicembre 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
19 febbraio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 gennaio 2016
Ultimo verificato
1 gennaio 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B0431010
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 .