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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506442-24-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.
This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 formulation 1 PF-07817883 | Experimental | Single oral dose of PF-07817883 tablet under fasted condition |
|
| Period 2 formulation 2 PF-07817883 | Experimental | Single oral dose of PF-07817883 tablet under fasted condition |
|
| Period 3 formulation 3 PF-07817883 | Experimental | Single oral dose of PF-07817883 tablet under fasted condition |
|
| Period 4 formulation 4 PF-07817883 | Experimental | Single oral dose of PF-07817883 tablet under fasted condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: PF-07817883 | Drug | PF-07817883 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07817883 | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period | |
| Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883 | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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Inclusion Criteria:
Exclusion Criteria:
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Positive test result for SARS-CoV-2 infection at admission
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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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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A total of 12 participants were enrolled and randomized in this study to 1 of the 4 study treatment sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1: A Then B Then C Then D | Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 milligram (mg) tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| FG001 | Treatment Sequence 2: B Then D Then A Then C | Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| FG002 | Treatment Sequence 3: C Then A Then D Then B | Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| FG003 | Treatment Sequence 4: D Then C Then B Then A | Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (3 Days) |
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| Treatment Period 2 (3 Days) |
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| Treatment Period 3 (3 Days) |
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| Treatment Period 4 (3 Days) |
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Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1: A Then B Then C Then D | Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| 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 | Maximum Observed Plasma Concentration (Cmax) of PF-07817883 | Pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period |
|
From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)
Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.
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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 | Treatment A: PF-07817883 300 mg Reference Formulation | Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Aug 24, 2023 | Dec 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2023 | Dec 23, 2024 | SAP_001.pdf |
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4 period 4 sequence crossover design
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This is an open-label study.
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| From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) |
| Number of Participants With Laboratory Test Abnormalities | Laboratory parameters included hematology (eosinophils/leukocytes [%] greater than [>] 1.2*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal [>=] to 1). | From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days) |
| Number of Participants With Clinically Significant Abnormality in Vital Signs | Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (>=) 30 mmHg increase, change from baseline >=30 mmHg decrease; DBP: value <50 mmHg, change from baseline >=20 mmHg increase, change from baseline >=20 mmHg decrease; PR: value <40 beats per minute (bpm), value greater than (>) 120 bpm. | From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days) |
| Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG) | Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (>=300 millisecond [msec], percent [%] change from baseline >=25 to 50%), QRS duration (>=140 msec, %change from baseline >=50%), corrected QT interval using Fridericia's formula (QTcF) (>500 msec, %change from baseline >60 msec, 450 msec\ | From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days) |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Treatment Sequence 2: B Then D Then A Then C | Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| BG002 | Treatment Sequence 3: C Then A Then D Then B | Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| BG003 | Treatment Sequence 4: D Then C Then B Then A | Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Treatment C: PF-07817883 300 mg Test Formulation 2 | Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period. |
| OG003 | Treatment D: PF-07817883 300 mg Test Formulation 3 | Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period. |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883 | PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period |
|
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | Laboratory parameters included hematology (eosinophils/leukocytes [%] greater than [>] 1.2*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal [>=] to 1). | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormality in Vital Signs | Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (>=) 30 mmHg increase, change from baseline >=30 mmHg decrease; DBP: value <50 mmHg, change from baseline >=20 mmHg increase, change from baseline >=20 mmHg decrease; PR: value <40 beats per minute (bpm), value greater than (>) 120 bpm. | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG) | Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (>=300 millisecond [msec], percent [%] change from baseline >=25 to 50%), QRS duration (>=140 msec, %change from baseline >=50%), corrected QT interval using Fridericia's formula (QTcF) (>500 msec, %change from baseline >60 msec, 450 msec\ | Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Treatment B: PF-07817883 300 mg Test Formulation 1 | Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG002 | Treatment C: PF-07817883 300 mg Test Formulation 2 | Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG003 | Treatment D: PF-07817883 300 mg Test Formulation 3 | Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period. | 0 | 11 | 0 | 11 | 2 | 11 |
| Lip dry | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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.
Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages. |
| Ratio of Adjusted Geometric Means |
| 125.07 |
| 2-Sided |
| 90 |
| 110.81 |
| 141.17 |
| Other |
| Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages. | Ratio of Adjusted Geometric Means | 121.75 | 2-Sided | 90 | 108.65 | 136.43 | Other |