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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504411-32-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to compare how healthy adults process Etrasimod when taken in different forms. One form is Etrasimod taken without food. The other form is Etrasimod mixed with water and 3 different foods. The types of food used are applesauce, chocolate pudding or yogurt.
The study is seeking participants who are:
The study will take up to 2.5 months, including the screening period. Participants will have to stay at the study clinic for at least 45 days. This includes 5 study periods in total.
Participants will take Etrasimod as a tablet by mouth without food. Participants will also take Etrasimod sprinkled in soft food or water. Blood samples will be taken both before and after participants take Etrasimod. Participants will also answer questions for taste assessment purposes. 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 |
|---|---|---|---|
| Sequence 1 | Experimental | Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
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| Sequence 2 | Experimental | Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
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| Sequence 3 | Experimental | Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estraimod Immediate Release (IR) | Drug | an immediate release tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | AUClast was calculated using linear/log trapezoidal method. | At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period |
| Maximum Observed Plasma Concentration (Cmax) for Etrasimod | At pre-dose and 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 |
|---|---|---|
| Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | Heart rate was measured in beats per minute. | Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
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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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All participants received at least one dose of etrasimod prepared in different vehicles.
A total of 16 participants were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence: A Then B Then C Then D Then E | Participants were randomized to receive a single oral dose of etrasimod 2 milligram (mg) clinical immediate release (IR) tablet with 240 milliliter (ml) of water on Day 1 of Period 1 under fasted conditions as reference (Treatment A) followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml water (Treatment D) as test 3 on Day 1 of Period 4 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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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 | Jun 1, 2023 | Nov 22, 2024 |
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| Sequence 4 | Experimental | Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) |
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| Etrasimod Mini Tab in water | Drug | very small tablet mixed in water |
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| Etrasimod Mini Tab in chocolate pudding | Drug | very small tablet mixed in chocolate pudding |
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| Etrasimod Mini Tab in yogurt | Drug | Very small tablet mixed in yogurt |
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| Etrasimod Mini Tab in applesauce | Drug | Very small tablet mixed in applesauce |
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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 following start of treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose, met one or more of the criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect. AEs included SAEs and all non-SAEs. |
| From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days) |
| Number of Participants With Clinical Laboratory Abnormalities | Clinical laboratory abnormalities test criteria included haematology: lymphocytes (10^3/ mm^3) and lymphocytes/leukocytes percentage (%) less than (<) 0.8* lower limit of normal (LLN), neutrophils, eosinophils, monocytes (10^3/mm^3), eosinophils/leukocytes monocytes/leukocytes (%) more than (>) 1.2* upper limit of normal (ULN); clinical chemistry: bicarbonate milliequivalents per liter (mEq/L) > 1.1* ULN; Urinalysis: urine hemoglobin, nitrite, leukocyte esterase greater than or equal to (>=) 1 and squamous epithelial cells /low power field (/LPF) > 4. Number of participants meeting any clinical laboratory abnormalities criteria is reported in this outcome measure. | Up to Day 45 |
| Number of Participants According to Categorization of Vital Signs Results | Supine blood pressure (SBP) and pulse rate (PR) were measured. Vital sign criteria included: Systolic BP: <90 millimeter of mercury [mmHg]; Systolic BP change from baseline: maximum increase and decrease >=30 mmHg; Diastolic BP < 50 mmHg; Diastolic BP change from baseline: maximum decrease and increase >=20 mmHg; pulse rate <40 and >120 beats per minute. | Up to Day 45 |
| Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | Standard 12-lead ECGs were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: QTcF interval, aggregate (milliseconds [msec]) 450 < Value <= 480, 480 < value <= 500, value > 500; 30 <= Change <= 60; Change > 60. Participants with any ECG abnormality criteria were reported in this outcome measure. | Up to Day 45 |
| Assessment of Mouth Feel Based on Palatability Questionnaire | Participants were required to answer mouth feel (such as grittiness, stickiness, waxiness) of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse mouth feel. | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
| Assessment of Bitterness Based on Palatability Questionnaire | Participants were required to tell about the degree of bitterness of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse bitterness. | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
| Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | Participants were required to tell about the degree of palatability attribute of tongue/mouth burns of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more tongue/mouth burns. | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
| Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | Participants were required to tell the palatability attribute of throat burn of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more throat burn. | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
| Assessment of Overall Liking Based on Palatability Questionnaire | Participants were required to tell the palatability attribute of overall liking of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated less overall liking. | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
| FG001 | Treatment Sequence: B Then D Then A Then C Then E | Participants were randomized to receive a single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5ml water (Treatment D) as test 3 on Day 1 of Period 4 followed by single oral dose of etrasimod 2 mg clinical IR tablet (Treatment A) as reference with 240 ml of water on Day 1 Period 1 under fasted conditions, followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3 followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose. |
| FG002 | Treatment Sequence: C Then A Then D Then B Then E | Participants were randomized to receive a single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3. Followed by single oral dose of etrasimod 2 mg clinical IR tablet (Treatment A) as reference with 240 ml of water on Day 1 of Period 1 under fasted conditions, followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml water (Treatment D) as test 3 on Day 1 of Period 4 , Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2, followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose. |
| FG003 | Treatment Sequence: D Then C Then B Then A Then E | Participants were randomized to receive a single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml water (Treatment D) as test 3 on Day 1 of Period 4. Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml chocolate pudding (Treatment C) as test 2 on Day 1 of Period 3. Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml applesauce (Treatment B) as test 1 on Day 1 of Period 2, followed by single oral dose of etrasimod 2 mg clinical IR tablet with 240 ml of water on Day 1 of Period 1 of each period under fasted conditions (Treatment A) as reference. Followed by single oral dose of etrasimod 2 mg mini tablets mixed with 5 ml yogurt (Treatment E) as test 4 on Day 1 of Period 5. There was a washout period of 9 days between each dose. |
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| NOT COMPLETED |
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| Washout Period |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| Washout Period |
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| Treatment Period 4 |
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| Treatment Period 5 |
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Safety analysis set (SAS) included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who were randomized to receive any of the treatment sequence in any of the period were included. |
| Units | Counts |
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| Participants |
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| 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 (NIH/OMB) | Count of Participants | Participants |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | AUClast was calculated using linear/log trapezoidal method. | Pharmacokinetic (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) | At pre-dose and 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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| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | AUCinf was calculated as AUClast + (Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. | 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 | At pre-dose and 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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| Primary | Maximum Observed Plasma Concentration (Cmax) for Etrasimod | 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 | At pre-dose and 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 at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | Heart rate was measured in beats per minute. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Mean | Standard Deviation | Beats per minute | Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1 |
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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 following start of treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose, met one or more of the criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect. AEs included SAEs and all non-SAEs. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days) |
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| Secondary | Number of Participants With Clinical Laboratory Abnormalities | Clinical laboratory abnormalities test criteria included haematology: lymphocytes (10^3/ mm^3) and lymphocytes/leukocytes percentage (%) less than (<) 0.8* lower limit of normal (LLN), neutrophils, eosinophils, monocytes (10^3/mm^3), eosinophils/leukocytes monocytes/leukocytes (%) more than (>) 1.2* upper limit of normal (ULN); clinical chemistry: bicarbonate milliequivalents per liter (mEq/L) > 1.1* ULN; Urinalysis: urine hemoglobin, nitrite, leukocyte esterase greater than or equal to (>=) 1 and squamous epithelial cells /low power field (/LPF) > 4. Number of participants meeting any clinical laboratory abnormalities criteria is reported in this outcome measure. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | Up to Day 45 |
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| Secondary | Number of Participants According to Categorization of Vital Signs Results | Supine blood pressure (SBP) and pulse rate (PR) were measured. Vital sign criteria included: Systolic BP: <90 millimeter of mercury [mmHg]; Systolic BP change from baseline: maximum increase and decrease >=30 mmHg; Diastolic BP < 50 mmHg; Diastolic BP change from baseline: maximum decrease and increase >=20 mmHg; pulse rate <40 and >120 beats per minute. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | Up to Day 45 |
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| Secondary | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | Standard 12-lead ECGs were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: QTcF interval, aggregate (milliseconds [msec]) 450 < Value <= 480, 480 < value <= 500, value > 500; 30 <= Change <= 60; Change > 60. Participants with any ECG abnormality criteria were reported in this outcome measure. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. | Posted | Count of Participants | Participants | Up to Day 45 |
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| Secondary | Assessment of Mouth Feel Based on Palatability Questionnaire | Participants were required to answer mouth feel (such as grittiness, stickiness, waxiness) of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse mouth feel. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) [Test]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Score on a scale | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
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| Secondary | Assessment of Bitterness Based on Palatability Questionnaire | Participants were required to tell about the degree of bitterness of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse bitterness. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) [Test]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Score on a scale | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
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| Secondary | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | Participants were required to tell about the degree of palatability attribute of tongue/mouth burns of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more tongue/mouth burns. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) [Test]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Score on a scale | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
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| Secondary | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | Participants were required to tell the palatability attribute of throat burn of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more throat burn. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) [Test]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Score on a scale | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
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| Secondary | Assessment of Overall Liking Based on Palatability Questionnaire | Participants were required to tell the palatability attribute of overall liking of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated less overall liking. | SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. As specified in protocol, data for 2mg-IR tablet (Reference) arm was not evaluated because it was planned to assess palatability of mini tabs in each vehicle (applesauce, chocolate pudding, water and yogurt) [Test]. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Score on a scale | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period |
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From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
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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 | Etrasimod 2 mg IR Tablet | Participants received etrasimod 2 mg IR tablet with volume of 240 ml of water on Day 1 of Period 1, 2, 3 or 4 under fasted conditions. | 0 | 16 | 0 | 16 | 7 | 16 |
| EG001 | Etrasimod 2 mg Mini Tablets in Applesauce | Participants received etrasimod 2mg mini tablets with 5 ml applesauce, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. | 0 | 15 | 0 | 15 | 10 | 15 |
| EG002 | Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition. | 0 | 16 | 0 | 16 | 9 | 16 |
| EG003 | Etrasimod 2 mg Mini Tablets in Water | Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. | 0 | 16 | 0 | 16 | 8 | 16 |
| EG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. | 0 | 16 | 0 | 16 | 11 | 16 |
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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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| Ear pain | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Asthenopia | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Photopsia | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Change of bowel habit | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Puncture site erythema | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vessel puncture site erythema | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Any untoward findings identified on physical examination during the active collection period were captured as adverse events, if those findings met the definition of an AE.
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.
| 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 | May 25, 2023 | Nov 22, 2024 | SAP_001.pdf |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. | Ratio of adjusted geometric means | 94.96 | 2-Sided | 90 | 91.69 | 98.34 | The ratio and 90% CIs are expressed as percentages. | Equivalence | For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range. |
| Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. | Ratio of adjusted geometric means | 85.86 | 2-Sided | 90 | 82.90 | 88.92 | The ratio and 90% CIs are expressed as percentages. | Equivalence | For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range. |
| Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. | Ratio of adjusted geometric means | 93.24 | 2-Sided | 90 | 89.76 | 96.84 | The ratio and 90% CIs are expressed as percentages. | Equivalence | For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range. |
Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition.
| OG003 | Etrasimod 2 mg Mini Tablets in Water | Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
|
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
|
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| OG002 | Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Water | Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| OG002 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding |
Participants received etrasimod 2mg mini tablets with 5 ml chocolate pudding, followed by approximately 235 mL water on Day 1 of period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Water | Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| OG003 | Etrasimod 2 mg Mini Tablets in Water | Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| OG003 | Etrasimod 2 mg Mini Tablets in Water | Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG004 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| Etrasimod 2 mg Mini Tablets in Water |
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| Etrasimod 2 mg Mini Tablets in Water |
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| OG002 |
| Etrasimod 2 mg Mini Tablets in Water |
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| Etrasimod 2 mg Mini Tablets in Water |
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
|
| Etrasimod 2 mg Mini Tablets in Water |
Participants received etrasimod 2mg mini tablets with 5 ml water, followed by approximately 235 mL water on Day 1 of Period 1, 2, 3 or 4 under fasted condition. |
| OG003 | Etrasimod 2 mg Mini Tablets in Yogurt | Participants received etrasimod 2mg mini tablets with 5 ml yogurt, followed by approximately 235 mL of water on Day 1 of Period 5 under fasted condition. |
|
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