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| ID | Type | Description | Link |
|---|---|---|---|
| C5041034 Sub-Study | Other Identifier | Alias Study Number | |
| 2023-508119-22-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.
The study is seeking participants who are:
The study will take up to 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods.
Participants will take Etrasimod as a tablet by mouth without food. Blood samples will be taken both before and after participants take Etrasimod. Participants will also use wearable devices to assess blood pressure, heart rate and take further blood samples. A follow-up phone call will be made 20 to 27 days after the last study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Sequence | Experimental | Single oral dose of etrasimod 2mg tablet under fasted conditions with site staff led assessments and training on how to use wearable sensors followed by single oral dose 2mg tablet under fasted conditions with participant led assessments with wearable sensors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod Immediate Release (IR) | Drug | An immediate release tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling | AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period |
| Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling | AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling | AUCinf was calculated as AUClast + (Clast*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24 of Etrasimod: Tasso and Venous PK Sampling | AUC0-24 was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. |
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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 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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For secondary pharmacokinetic (PK) outcome measures' analysis, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study [NCT05956002] is used for comparison. These participants were not enrolled in the present study C5041050 [NCT06140290], only the relevant historical data was used for comparison as per the objectives.
A total of 8 participants were enrolled in this present study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Etrasimod 2mg (Treatment F, With Practice Session) | Participants received a single oral dose of Etrasimod 2 milligram (mg) immediate release (IR) with 240 milliliter (mL) water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2. |
| FG001 | Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) | Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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Safety analysis set (SAS) included all participants who took at least 1 dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants: Etrasimod 2mg | All participants who received study treatment either in Period 1 or 2 of the study. |
| 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 | Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling | AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter (ng*hr/mL ) | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period |
|
Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
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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 | Period 1: Etrasimod 2mg (Treatment F, With Practice Session) | Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.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 | Nov 6, 2023 | Feb 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2023 | Feb 28, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656249 | etrasimod |
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| Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling |
PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. |
| Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period |
| AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling | AUC24hr-last was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| AUCinf for Etrasimod: Tasso and Venous PK Sampling | AUCinf was calculated as AUClast + (Clast*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Cmax for Etrasimod: Tasso and Venous PK Sampling | PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1 | Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate electrocardiogram (ECG) HR measurements collected at pre-dose (0 hour) on Day 1 of each period. | Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each period |
| Change From Baseline to Nadir in HR at Day 1 | Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate ECG HR measurements collected at pre-dose (0 hour) on Day 1 of each period. Nadir HR was taken as the minimum HR from all ECGs taken post-Etrasimod on day 1 of each period. If Nadir HR was attained at multiple post-dose time points on Day 1, only the latest time point was summarized. | Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each period |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of study treatment up to 35 days post last dose of study treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect. | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
| Number of Participants With Clinically Significant Findings in Laboratory Abnormalities | Clinical laboratory abnormalities test criteria included, a) hematology: lymphocytes (10^3/millimeter [mm)^3]) and lymphocytes/leukocytes percentage (%) less than (<) 0.8* lower limit of normal (LLN), eosinophils (10^3/mm^3), eosinophils/leukocytes (%) and monocytes (10^3/mm^3) greater than (>)1.2* upper limit of normal (ULN); b) Urinalysis: urine glucose, ketones, urine hemoglobin and bilirubin, leukocyte esterase greater than equal to (>=) 1. Clinical significance of laboratory abnormalities was determined by the investigator. | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
| Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure systolic and diastolic millimeter of mercury (mmHg) and pulse rate (beats/min). Clinical significance of vital signs abnormalities was determined by the investigator. | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
| Number of Participants With Clinically Significant Findings in Physical Examination | A complete physical examination test included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination test included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Clinical significance of physical examination abnormalities was determined by the investigator. | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
| Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria | ECG findings criteria for QT interval corrected using Fridericia's formula (QTcF) were as: 450 millisecond (msec) < value less than equal (<=) 480 msec, 480 msec < value <=500 msec, >500 msec, 30 msec <= change from baseline <=60 msec, change from baseline >60 msec. | From Baseline (Day 1) maximum up to Day 17 |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2. |
| OG001 | Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) | Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices. |
|
|
|
| Primary | Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling | AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
|
|
|
|
| Primary | Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling | AUCinf was calculated as AUClast + (Clast*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
|
|
|
|
| Primary | Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling | PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter (ng/mL) | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
|
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|
|
| Secondary | AUC0-24 of Etrasimod: Tasso and Venous PK Sampling | AUC0-24 was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period |
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| Secondary | AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling | AUC24hr-last was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
|
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|
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| Secondary | AUCinf for Etrasimod: Tasso and Venous PK Sampling | AUCinf was calculated as AUClast + (Clast*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
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| Secondary | Cmax for Etrasimod: Tasso and Venous PK Sampling | PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose. | PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
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| Secondary | Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1 | Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate electrocardiogram (ECG) HR measurements collected at pre-dose (0 hour) on Day 1 of each period. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | Beats/minute | Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each period |
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| Secondary | Change From Baseline to Nadir in HR at Day 1 | Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate ECG HR measurements collected at pre-dose (0 hour) on Day 1 of each period. Nadir HR was taken as the minimum HR from all ECGs taken post-Etrasimod on day 1 of each period. If Nadir HR was attained at multiple post-dose time points on Day 1, only the latest time point was summarized. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Mean | Standard Deviation | Beats/ min | Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each period |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of study treatment up to 35 days post last dose of study treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
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| Secondary | Number of Participants With Clinically Significant Findings in Laboratory Abnormalities | Clinical laboratory abnormalities test criteria included, a) hematology: lymphocytes (10^3/millimeter [mm)^3]) and lymphocytes/leukocytes percentage (%) less than (<) 0.8* lower limit of normal (LLN), eosinophils (10^3/mm^3), eosinophils/leukocytes (%) and monocytes (10^3/mm^3) greater than (>)1.2* upper limit of normal (ULN); b) Urinalysis: urine glucose, ketones, urine hemoglobin and bilirubin, leukocyte esterase greater than equal to (>=) 1. Clinical significance of laboratory abnormalities was determined by the investigator. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
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| Secondary | Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure systolic and diastolic millimeter of mercury (mmHg) and pulse rate (beats/min). Clinical significance of vital signs abnormalities was determined by the investigator. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | No | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
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| Secondary | Number of Participants With Clinically Significant Findings in Physical Examination | A complete physical examination test included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination test included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Clinical significance of physical examination abnormalities was determined by the investigator. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days) |
|
|
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| Secondary | Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria | ECG findings criteria for QT interval corrected using Fridericia's formula (QTcF) were as: 450 millisecond (msec) < value less than equal (<=) 480 msec, 480 msec < value <=500 msec, >500 msec, 30 msec <= change from baseline <=60 msec, change from baseline >60 msec. | SAS included all participants who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From Baseline (Day 1) maximum up to Day 17 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 7 |
| 8 |
| EG001 | Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) | Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices. | 0 | 7 | 0 | 7 | 5 | 7 |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Puncture site injury | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Device issue | Product Issues | MedDRA v26.1 | Non-systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | 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 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.
| Analysis was performed using ANOVA model with treatment as a fixed effect. | Ratio of Adjusted Geometric Means | 102.71 | 2-Sided | 90 | 86.33 | 122.19 | Ratio (Test/Reference) and its associated 90% CI were expressed as percentages. | Equivalence | The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment. |
| Analysis was performed using ANOVA model with treatment as a fixed effect. | Ratio of Adjusted Geometric Means | 97.98 | 2-Sided | 90 | 76.99 | 124.70 | Ratio (Test/Reference) and its associated 90% CI were expressed as percentages. | Equivalence | The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment. |
| Analysis was performed using ANOVA model with treatment as a fixed effect. | Ratio of Adjusted Geometric Means | 97.54 | 2-Sided | 90 | 78.74 | 120.83 | Ratio (Test/Reference) and its associated 90% CI were expressed as percentages. | Equivalence | The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment. |
| Analysis was performed using ANOVA model with treatment as a fixed effect. | Ratio of Adjusted Geometric Means | 103.36 | 2-Sided | 90 | 86.04 | 124.16 | Ratio (Test/Reference) and its associated 90% CI were expressed as percentages. | Equivalence | The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment. |
| Change at 3 hours |
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| Change at 4 hours |
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| Change at 5 hours |
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| Change at 6 hours |
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| Change at 8 hours |
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| Change at 24 hours |
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| Value > 500 msec |
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| 30 msec <= Change from baseline <= 60 msec |
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| Change from baseline > 60 msec |
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