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Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04191834 30mg | Experimental |
| |
| PF-04191834 100mg | Experimental |
| |
| PF-04191834 2000mg | Experimental |
| |
| zileuton | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04191834 | Drug | 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second | Baseline, 12 hours (hrs) post-dose |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second | Baseline, 24 hours (hrs) post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible | Baseline, 12 hours (hrs) post-dose |
| Change From Baseline in Forced Vital Capacity (FVC) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
| Maximum Observed Plasma Concentration (Cmax) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Baltimore | Maryland | 21225 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 | Placebo/Zileuton CR 1200 mg/PF-04191834 30 mg/PF-04191834 2000 mg/PF-04191834 100 mg |
| FG001 | Treatment Sequence 2 | PF-04191834 100 mg/PF-04191834 30 mg/PF-04191834 2000 mg/Placebo/Zileuton CR 1200 mg |
| FG002 | Treatment Sequence 3 | PF-04191834 2000 mg/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 30 mg/Placebo |
| FG003 | Treatment Sequence 4 | PF-04191834 30 mg/Placebo/PF-04191834 100 mg/Zileuton CR 1200 mg/PF-04191834 2000 mg |
| FG004 | Treatment Sequence 5 | Zileuton CR 1200 mg/PF-04191834 2000 mg/Placebo/PF-04191834 100 mg/PF-04191834 30 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 |
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| Intervention Period 2 |
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| Intervention Period 3 |
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| Intervention Period 4 |
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| Intervention Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants receiving any of the 5 treatments (PF-04191834 30 mg, PF-04191834 100 mg, PF-04191834 2000 mg, Zileuton CR 1200 mg and Placebo) in a randomized fashion first |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | Posted | Mean | Standard Deviation | L | Baseline, 12 hours (hrs) post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received single oral dose of placebo for zileuton CR tablets or placebo for PF-04191834 oral aqueous dispersion in any treatment period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA v12.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C063449 | zileuton |
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| PF-04191834 | Drug | 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose. |
|
| PF-04191834 | Drug | 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose |
|
| zileuton | Drug | 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose. |
|
| Placebo | Drug | 2 x placebo tablets + placebo oral dispersion, single dose. |
|
The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible |
| Baseline,24 hours (hrs) post-dose |
| Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity | Baseline, 12 hours (hrs) post-dose |
| Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity | Baseline, 24 hours (hrs) post-dose |
| Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 14 and 24 hours following dosing in each period. |
| North Dartmouth |
| Massachusetts |
| 02747 |
| United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49007 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG002 | PF-04191834 100 mg | Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period |
| OG003 | PF-04191834 2000 mg | Participants received a single oral dose of PF-04191834 2000 mg in any treatment period |
| OG004 | Zileuton CR 1200 mg | Paticipants received a single oral dose of zileuton CR 1200 mg (2 x 600 mg tablets) in any treatment period |
|
|
| Primary | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | Posted | Mean | Standard Deviation | L | Baseline, 24 hours (hrs) post-dose |
|
|
|
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | Posted | Mean | Standard Deviation | L | Baseline, 12 hours (hrs) post-dose |
|
|
|
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | Posted | Mean | Standard Deviation | L | Baseline,24 hours (hrs) post-dose |
|
|
|
| Secondary | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | Posted | Mean | Standard Deviation | L/Sec | Baseline, 12 hours (hrs) post-dose |
|
|
|
| Secondary | Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity | All enrolled participants treated who had at least 1 concentration in at least 1 treatment period | Posted | Mean | Standard Deviation | L | Baseline, 24 hours (hrs) post-dose |
|
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period. | Posted | Mean | Standard Deviation | ng*h/mL | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
|
|
|
| Other Pre-specified | Maximum Observed Plasma Concentration (Cmax) | All enrolled subjects treated who have at least one of the PK parameters of interest in at least one treatment period. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
|
|
|
| Other Pre-specified | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Posted | Median | Full Range | hrs | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
|
|
|
| Other Pre-specified | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level. | Posted | Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. |
|
|
| Other Pre-specified | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | Since the PK sample collection only occurred until 24 hours and the approximate t1/2 at all doses appeared to be >10 hours, t1/2 and area under the plasma concentration versus time curve until infinity (AUCinf) are not reported at any dose level. | Posted | 14 and 24 hours following dosing in each period. |
|
|
| 0 |
| 15 |
| 9 |
| 15 |
| EG001 | PF-04191834 30 mg | Participants received a single oral dose of PF-04191834 30 mg in any treatment period | 0 | 14 | 4 | 14 |
| EG002 | PF-04191834 100 mg | Participants received a single oral dose of PF-04191834 100 mg single dose in any treatment period | 0 | 15 | 10 | 15 |
| EG003 | PF-04191834 2000 mg | Participants received a single oral dose of PF-04191834 2000 mg in any treatment period | 0 | 15 | 4 | 15 |
| EG004 | Zileuton CR 1200 mg | Paticipants received single oral dose of zileuton CR1200 mg (2 x 600 mg tablets) in any treatment period | 0 | 15 | 12 | 15 |
| Dry mouth | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA v12.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v12.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract | Infections and infestations | MedDRA v12.0 | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA v12.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v12.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA v12.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Change at 24 Hours Postdose |
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| Change at 12 Hours Postdose |
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| Change at 24 Hours Postdose |
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| Change at 12 Hours Postdose |
|
| Change at 24 Hours Postdose |
|