A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
22 januari 2016 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
22
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Berlin, Tyskland, 10117
- Pfizer Investigational Site
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Placebo-jämförare: Placebo
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oral inhaled formulation, single dose
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Aktiv komparator: aktiv komparator
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oral inhaled formulation, single dose
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)
Tidsram: 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.
|
Baseline, 24, 24.5 hrs post-dose
|
|
Maximum Observed Plasma Concentration (Cmax)
Tidsram: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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
Tidsram: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
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).
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tidsram: 1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Tidsram: 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).
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
|
Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration
Tidsram: 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
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)]
Tidsram: 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-∞).
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
|
Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time
Tidsram: 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).
|
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)
Tidsram: 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.
|
1 hr pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 36, 48 hrs post-dose
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peak Forced Expiratory Volume in 1 Second (FEV1)
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
|
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)
Tidsram: Baseline, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 24.5, 36, 48 hrs pot-dose
|
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
|
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2010
Primärt slutförande (Faktisk)
1 juni 2010
Avslutad studie (Faktisk)
1 juni 2010
Studieregistreringsdatum
Först inskickad
15 december 2009
Först inskickad som uppfyllde QC-kriterierna
15 december 2009
Första postat (Uppskatta)
16 december 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
19 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 januari 2016
Senast verifierad
1 januari 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B0431010
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