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| ID | Type | Description | Link |
|---|---|---|---|
| OBI | Other Identifier | Alias Study Number |
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This will be an open-label, randomized, 2-treatment, 2-period, crossover single-dose study in approximately 134 healthy adult participants. Participants will be randomized into 2 sequences of treatment as described in the following table of Intervention Groups and Duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06881894 by on-body injector (OBI) | Other | PF-06881894 given by on-body injector (OBI) as test arm, 6 mg administered as a single SC injection |
|
| PF-06881894 by prefilled syringe (PFS) | Other | PF-06881894 given by prefilled syringe (PFS) as reference arm, 6 mg administered as a single SC injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06881894 by on-body injector | Combination Product | PF-06881894 given by on-body injector (OBI), 6 mg administered as a single SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of PF-06881894 | Cmax of PF-06881894 was defined as maximum serum concentration of PF-06881894. Observed directly from data. | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
| Area Under the Serum Drug Concentration-time Profile From Time 0 to the Last Quantifiable Concentration (AUClast) of PF-06881894 | AUClast of PF-06881894 was defined as area under the serum drug concentration-time profile from time 0 to the last quantifiable concentration. Linear/Log trapezoidal method was used. | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
| Area Under the Serum Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06881894 | AUCinf of PF-06881894 was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time. | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Cmax (Tmax) of PF-06881894 | Tmax of PF-06881894 was defined as time for Cmax. Observed directly from data as time of first occurrence. | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
| Terminal Serum Elimination Half-life (t½) of PF-06881894 |
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Inclusion Criteria:
Exclusion Criteria:
Lack of adequate hepatic reserve, defined by AST/SGOT or ALT/SGPT >= 1.5 × ULN of the reference laboratory; TBili >= 1.5 × ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is <= ULN.
Lack of renal reserve, defined by serum creatinine of >= 1.2 × ULN for reference laboratory or eGFR of <= 80 mL/minute; or known history of glomerulonephritis.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Research Centers of America ( Hollywood ) |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This was an open-label, randomized, 2-treatment (PF-06881894 via prefilled syringe [PFS] or PF-06881894 via on-body injector [OBI]), 2-period, crossover single-dose study. A total of 371 participants were screened for this study; 141 participants were randomized to treatment and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06881894 PFS=>PF-06881894 OBI | Participants received PF-06881894 administered subcutaneously (SC) via PFS on Day 1 of Period 1, then followed by PF-06881894 administered SC via OBI on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2021 | Jul 21, 2023 |
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|
| PF-06881894 by prefilled syringe | Combination Product | PF-06881894 given by prefilled syringe (PFS), 6 mg administered as a single SC injection |
|
Terminal serum elimination half-life (t½) of PF-06881894 was defined as terminal half-life using Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
| Number of Participants With Treatment Emergent Adverse Events | Treatment-emergent were events between first dose and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. An AESI was one of scientific and medical concern specific to the sponsor's product or programme. Device related AE was an AE related to the use of an investigational medical device. AEs of ISR and ASR included injection site pain, injection site erythema, application site hemorrhage, application site pain, application site discomfort, application site bruise, and application site erythema. | From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months). |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Prism Research LLC dba Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | United States |
| PF-06881894 OBI=>PF-06881894 PFS |
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1, then followed by PF-06881894 administered SC via PFS on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments. |
| Assigned to Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose).
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06881894 PFS=>PF-06881894 OBI | Participants received PF-06881894 administered subcutaneously (SC) via PFS on Day 1 of Period 1, then followed by PF-06881894 administered SC via OBI on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments. |
| BG001 | PF-06881894 OBI=>PF-06881894 PFS | Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1, then followed by PF-06881894 administered SC via PFS on Day 1 of Period 2. There was a wash out period of at least 56 days between the 2 treatments. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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 | Maximum Serum Concentration (Cmax) of PF-06881894 | Cmax of PF-06881894 was defined as maximum serum concentration of PF-06881894. Observed directly from data. | The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid pharmacokinetic (PK) primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
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| Primary | Area Under the Serum Drug Concentration-time Profile From Time 0 to the Last Quantifiable Concentration (AUClast) of PF-06881894 | AUClast of PF-06881894 was defined as area under the serum drug concentration-time profile from time 0 to the last quantifiable concentration. Linear/Log trapezoidal method was used. | The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
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| Primary | Area Under the Serum Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06881894 | AUCinf of PF-06881894 was defined as area under the serum concentration-time profile from time 0 extrapolated to infinite time. | The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
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| Secondary | Time for Cmax (Tmax) of PF-06881894 | Tmax of PF-06881894 was defined as time for Cmax. Observed directly from data as time of first occurrence. | The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure. | Posted | Median | Full Range | hour | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
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| Secondary | Terminal Serum Elimination Half-life (t½) of PF-06881894 | Terminal serum elimination half-life (t½) of PF-06881894 was defined as terminal half-life using Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | The analysis population for each arm included all randomized participants who were fully dosed and had at least 1 valid PK primary result in at least 1 treatment period. "Number of Participants Analyzed" signifies number of participants evaluable/non-missing for this outcome measure. | Posted | Mean | Standard Deviation | hour | Within 1 hour prior to dose (Hour 0) and at 0.167 (10 min), 0.5, 1, 3, 6, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264 and 288 hours post-dose |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events | Treatment-emergent were events between first dose and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. An AESI was one of scientific and medical concern specific to the sponsor's product or programme. Device related AE was an AE related to the use of an investigational medical device. AEs of ISR and ASR included injection site pain, injection site erythema, application site hemorrhage, application site pain, application site discomfort, application site bruise, and application site erythema. | All participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete dose). Here, 'Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months). |
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From the first dose on Day 1 of Period 1 to the Period 2 Day 28 Visit (up to 5 months).
Adverse events analysis population included all participants who were randomized and received at least 1 dose of study intervention (regardless of complete or incomplete 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 | PF-06881894 PFS | Participants received PF-06881894 administered SC via PFS on Day 1 of Period 1 or Period 2. | 0 | 136 | 0 | 136 | 92 | 136 |
| EG001 | PF-06881894 OBI | Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2. | 0 | 136 | 0 | 136 | 96 | 136 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 25.0 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | 25.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 25.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 25.0 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 25.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 25.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | 25.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2022 | Jul 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Unknown |
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| Multiracial |
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| Participants |
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| PF-06881894 OBI |
Participants received PF-06881894 administered SC via OBI on Day 1 of Period 1 or Period 2. |
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