Healthy Participants
Conditions
Keywords
bioavailability, etrasimod, adult
Brief summary
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: * Aged 18 or older * Male or female who are healthy as determined by medical assessment * Body-mass index (BMI) of 16 to 32, and a total body weight \> 50kg. 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.
Interventions
DRUGEstraimod Immediate Release (IR)
an immediate release tablet
DRUGEtrasimod Mini Tab in water
very small tablet mixed in water
DRUGEtrasimod Mini Tab in chocolate pudding
very small tablet mixed in chocolate pudding
DRUGEtrasimod Mini Tab in yogurt
Very small tablet mixed in yogurt
DRUGEtrasimod Mini Tab in applesauce
Very small tablet mixed in applesauce
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants * BMI 16 to 32 kg/m2 * body weight more than 50kg
Exclusion criteria
* Ongoing or past history of significant medical conditions * Eye disorders such as macular edema or uveitis * Ongoing or recent infections * Use of prescription or non prescription medications within 7 days of first dose * Smoking or using nicotine products equivalent to more than 5 cigarettes per day * History of severe allergic or anaphylactic reactions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of 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 | AUClast was calculated using linear/log trapezoidal method. |
| Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of 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 | 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. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to Categorization of Vital Signs Results | Up to Day 45 | 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. |
| Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | Up to Day 45 | 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. |
| Assessment of Mouth Feel Based on Palatability Questionnaire | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period | 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. |
| Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1 | Heart rate was measured in beats per minute. |
| Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period | 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. |
| Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period | 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. |
| Assessment of Overall Liking Based on Palatability Questionnaire | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period | 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. |
| Assessment of Bitterness Based on Palatability Questionnaire | At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period | 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. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days) | 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. |
| Number of Participants With Clinical Laboratory Abnormalities | Up to Day 45 | 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. |
Countries
Belgium
Participant flow
Recruitment details
A total of 16 participants were enrolled in this study.
Pre-assignment details
All participants received at least one dose of etrasimod prepared in different vehicles.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants who were randomized to receive any of the treatment sequence in any of the period were included. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period 3 | Adverse Event | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 42.1 Years STANDARD_DEVIATION 11.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 7 / 16 | 10 / 15 | 9 / 16 | 8 / 16 | 11 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | 1694 ng*hr/mL | Geometric Coefficient of Variation 26 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | 1594 ng*hr/mL | Geometric Coefficient of Variation 20 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | 1605 ng*hr/mL | Geometric Coefficient of Variation 19 |
| Etrasimod 2 mg Mini Tablets in Water | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | 1447 ng*hr/mL | Geometric Coefficient of Variation 23 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod | 1580 ng*hr/mL | Geometric Coefficient of Variation 22 |
Comparison: Analysis was performed for etrasimod 2 mg mini tablets in applesauce 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.90% CI: [90.97, 97.89]
Comparison: 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.90% CI: [91.41, 98.2]
Comparison: 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.90% CI: [82.43, 88.55]
Comparison: 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.90% CI: [89.61, 97.1]
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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | 1620 Nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 26 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | 1529 Nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 19 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | 1538 Nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 19 |
| Etrasimod 2 mg Mini Tablets in Water | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | 1391 Nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 22 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod | 1510 Nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 22 |
Comparison: Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.90% CI: [91.33, 98.12]
Comparison: 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.90% CI: [91.69, 98.34]
Comparison: 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.90% CI: [82.9, 88.92]
Comparison: 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.90% CI: [89.76, 96.84]
Primary
Maximum Observed Plasma Concentration (Cmax) for Etrasimod
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Maximum Observed Plasma Concentration (Cmax) for Etrasimod | 43.18 Nanogram per milliliter | Geometric Coefficient of Variation 22 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Maximum Observed Plasma Concentration (Cmax) for Etrasimod | 40.44 Nanogram per milliliter | Geometric Coefficient of Variation 19 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Maximum Observed Plasma Concentration (Cmax) for Etrasimod | 40.03 Nanogram per milliliter | Geometric Coefficient of Variation 18 |
| Etrasimod 2 mg Mini Tablets in Water | Maximum Observed Plasma Concentration (Cmax) for Etrasimod | 37.67 Nanogram per milliliter | Geometric Coefficient of Variation 18 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Maximum Observed Plasma Concentration (Cmax) for Etrasimod | 39.98 Nanogram per milliliter | Geometric Coefficient of Variation 21 |
Comparison: Analysis was performed for etrasimod 2 mg mini tablets in applesauce 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.90% CI: [90.38, 99.22]
Comparison: 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.90% CI: [88.59, 97.04]
Comparison: 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.90% CI: [83.35, 91.31]
Comparison: 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.90% CI: [88.24, 97.17]
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.
Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Assessment of Bitterness Based on Palatability Questionnaire | At 5 minutes | 5.0 Score on a scale | Standard Deviation 7.41 |
| Etrasimod 2 mg IR Tablet | Assessment of Bitterness Based on Palatability Questionnaire | At 1 minute | 12.3 Score on a scale | Standard Deviation 17.26 |
| Etrasimod 2 mg IR Tablet | Assessment of Bitterness Based on Palatability Questionnaire | At 10 minutes | 4.2 Score on a scale | Standard Deviation 4.86 |
| Etrasimod 2 mg IR Tablet | Assessment of Bitterness Based on Palatability Questionnaire | At 20 minutes | 3.5 Score on a scale | Standard Deviation 3.91 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Bitterness Based on Palatability Questionnaire | At 5 minutes | 4.1 Score on a scale | Standard Deviation 4.92 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Bitterness Based on Palatability Questionnaire | At 10 minutes | 5.5 Score on a scale | Standard Deviation 6.53 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Bitterness Based on Palatability Questionnaire | At 1 minute | 4.3 Score on a scale | Standard Deviation 5.69 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Bitterness Based on Palatability Questionnaire | At 20 minutes | 4.2 Score on a scale | Standard Deviation 4.65 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Bitterness Based on Palatability Questionnaire | At 10 minutes | 9.9 Score on a scale | Standard Deviation 18.52 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Bitterness Based on Palatability Questionnaire | At 5 minutes | 8.3 Score on a scale | Standard Deviation 16.07 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Bitterness Based on Palatability Questionnaire | At 20 minutes | 9.3 Score on a scale | Standard Deviation 17.5 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Bitterness Based on Palatability Questionnaire | At 1 minute | 9.4 Score on a scale | Standard Deviation 17.02 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Bitterness Based on Palatability Questionnaire | At 20 minutes | 4.3 Score on a scale | Standard Deviation 5.49 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Bitterness Based on Palatability Questionnaire | At 1 minute | 8.9 Score on a scale | Standard Deviation 15.09 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Bitterness Based on Palatability Questionnaire | At 10 minutes | 7.8 Score on a scale | Standard Deviation 11.49 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Bitterness Based on Palatability Questionnaire | At 5 minutes | 7.9 Score on a scale | Standard Deviation 12.39 |
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.
Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 1 minute | 6.9 Score on a scale | Standard Deviation 13.48 |
| Etrasimod 2 mg IR Tablet | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 5 minutes | 6.6 Score on a scale | Standard Deviation 12.16 |
| Etrasimod 2 mg IR Tablet | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 10 minutes | 6.3 Score on a scale | Standard Deviation 12.12 |
| Etrasimod 2 mg IR Tablet | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 20 minutes | 6.2 Score on a scale | Standard Deviation 12.32 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 5 minutes | 3.6 Score on a scale | Standard Deviation 3.67 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 10 minutes | 5.3 Score on a scale | Standard Deviation 7.04 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 20 minutes | 3.6 Score on a scale | Standard Deviation 3.95 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 1 minute | 3.4 Score on a scale | Standard Deviation 3.77 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 10 minutes | 10.2 Score on a scale | Standard Deviation 18.69 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 5 minutes | 3.7 Score on a scale | Standard Deviation 3.46 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 20 minutes | 13.6 Score on a scale | Standard Deviation 25.19 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 1 minute | 4.0 Score on a scale | Standard Deviation 4.35 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 20 minutes | 8.8 Score on a scale | Standard Deviation 17.28 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 5 minutes | 6.8 Score on a scale | Standard Deviation 12.03 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 1 minute | 5.3 Score on a scale | Standard Deviation 7.04 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Likeness of Throat Burn Based on Palatability Questionnaire | At 10 minutes | 8.1 Score on a scale | Standard Deviation 17.98 |
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.
Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Assessment of Mouth Feel Based on Palatability Questionnaire | At 1 minute | 8.0 Score on a scale | Standard Deviation 10.34 |
| Etrasimod 2 mg IR Tablet | Assessment of Mouth Feel Based on Palatability Questionnaire | At 5 minutes | 6.9 Score on a scale | Standard Deviation 9.93 |
| Etrasimod 2 mg IR Tablet | Assessment of Mouth Feel Based on Palatability Questionnaire | At 10 minutes | 5.6 Score on a scale | Standard Deviation 10.27 |
| Etrasimod 2 mg IR Tablet | Assessment of Mouth Feel Based on Palatability Questionnaire | At 20 minutes | 7.0 Score on a scale | Standard Deviation 14.59 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Mouth Feel Based on Palatability Questionnaire | At 5 minutes | 4.7 Score on a scale | Standard Deviation 5.36 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Mouth Feel Based on Palatability Questionnaire | At 10 minutes | 6.6 Score on a scale | Standard Deviation 7.12 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Mouth Feel Based on Palatability Questionnaire | At 20 minutes | 5.6 Score on a scale | Standard Deviation 5.23 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Mouth Feel Based on Palatability Questionnaire | At 1 minute | 5.0 Score on a scale | Standard Deviation 7.21 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Mouth Feel Based on Palatability Questionnaire | At 10 minutes | 8.9 Score on a scale | Standard Deviation 18.04 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Mouth Feel Based on Palatability Questionnaire | At 5 minutes | 8.1 Score on a scale | Standard Deviation 15.84 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Mouth Feel Based on Palatability Questionnaire | At 20 minutes | 8.8 Score on a scale | Standard Deviation 16.22 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Mouth Feel Based on Palatability Questionnaire | At 1 minute | 9.6 Score on a scale | Standard Deviation 17.14 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Mouth Feel Based on Palatability Questionnaire | At 20 minutes | 4.8 Score on a scale | Standard Deviation 6.61 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Mouth Feel Based on Palatability Questionnaire | At 5 minutes | 8.4 Score on a scale | Standard Deviation 12.46 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Mouth Feel Based on Palatability Questionnaire | At 1 minute | 9.3 Score on a scale | Standard Deviation 10.03 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Mouth Feel Based on Palatability Questionnaire | At 10 minutes | 7.4 Score on a scale | Standard Deviation 9.16 |
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.
Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Assessment of Overall Liking Based on Palatability Questionnaire | At 1 minute | 8.9 Score on a scale | Standard Deviation 13.58 |
| Etrasimod 2 mg IR Tablet | Assessment of Overall Liking Based on Palatability Questionnaire | At 5 minutes | 6.8 Score on a scale | Standard Deviation 12.2 |
| Etrasimod 2 mg IR Tablet | Assessment of Overall Liking Based on Palatability Questionnaire | At 10 minutes | 6.5 Score on a scale | Standard Deviation 12.25 |
| Etrasimod 2 mg IR Tablet | Assessment of Overall Liking Based on Palatability Questionnaire | At 20 minutes | 6.6 Score on a scale | Standard Deviation 12.55 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Overall Liking Based on Palatability Questionnaire | At 5 minutes | 4.4 Score on a scale | Standard Deviation 3.76 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Overall Liking Based on Palatability Questionnaire | At 10 minutes | 5.4 Score on a scale | Standard Deviation 4.78 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Overall Liking Based on Palatability Questionnaire | At 20 minutes | 4.3 Score on a scale | Standard Deviation 4.01 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Overall Liking Based on Palatability Questionnaire | At 1 minute | 3.8 Score on a scale | Standard Deviation 4.9 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Overall Liking Based on Palatability Questionnaire | At 10 minutes | 9.2 Score on a scale | Standard Deviation 19.1 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Overall Liking Based on Palatability Questionnaire | At 5 minutes | 7.9 Score on a scale | Standard Deviation 16.55 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Overall Liking Based on Palatability Questionnaire | At 20 minutes | 9.2 Score on a scale | Standard Deviation 17.7 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Overall Liking Based on Palatability Questionnaire | At 1 minute | 8.1 Score on a scale | Standard Deviation 16.69 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Overall Liking Based on Palatability Questionnaire | At 20 minutes | 9.8 Score on a scale | Standard Deviation 16.31 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Overall Liking Based on Palatability Questionnaire | At 5 minutes | 10.1 Score on a scale | Standard Deviation 16.62 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Overall Liking Based on Palatability Questionnaire | At 1 minute | 10.4 Score on a scale | Standard Deviation 14.24 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Overall Liking Based on Palatability Questionnaire | At 10 minutes | 10.1 Score on a scale | Standard Deviation 18.64 |
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.
Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 1 minute | 3.4 Score on a scale | Standard Deviation 3.81 |
| Etrasimod 2 mg IR Tablet | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 5 minutes | 3.1 Score on a scale | Standard Deviation 3.76 |
| Etrasimod 2 mg IR Tablet | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 10 minutes | 3.0 Score on a scale | Standard Deviation 3.8 |
| Etrasimod 2 mg IR Tablet | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 20 minutes | 3.1 Score on a scale | Standard Deviation 3.56 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 5 minutes | 3.1 Score on a scale | Standard Deviation 3.26 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 10 minutes | 3.6 Score on a scale | Standard Deviation 3.44 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 20 minutes | 4.3 Score on a scale | Standard Deviation 4.44 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 1 minute | 2.7 Score on a scale | Standard Deviation 3.48 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 10 minutes | 4.2 Score on a scale | Standard Deviation 3.36 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 5 minutes | 3.8 Score on a scale | Standard Deviation 3.34 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 20 minutes | 7.1 Score on a scale | Standard Deviation 10.16 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 1 minute | 3.9 Score on a scale | Standard Deviation 4.04 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 20 minutes | 3.0 Score on a scale | Standard Deviation 2.63 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 5 minutes | 3.4 Score on a scale | Standard Deviation 4.26 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 1 minute | 4.8 Score on a scale | Standard Deviation 5.26 |
| Etrasimod 2 mg Mini Tablets in Water | Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire | At 10 minutes | 3.6 Score on a scale | Standard Deviation 4.1 |
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.
Time frame: Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1
Population: SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 1 hour | -6.3 Beats per minute | Standard Deviation 4.08 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 2 hours | -10.4 Beats per minute | Standard Deviation 3.03 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 3 hours | -10.8 Beats per minute | Standard Deviation 4.6 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 4 hours | -9.9 Beats per minute | Standard Deviation 4.84 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 5 hours | -4.1 Beats per minute | Standard Deviation 4.52 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 6 hours | -3.4 Beats per minute | Standard Deviation 4.67 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 8 hours | -5.3 Beats per minute | Standard Deviation 4.75 |
| Etrasimod 2 mg IR Tablet | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 24 hours | -6.4 Beats per minute | Standard Deviation 3.14 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 3 hours | -9.9 Beats per minute | Standard Deviation 2.97 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 6 hours | -2.0 Beats per minute | Standard Deviation 3.96 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 1 hour | -6.0 Beats per minute | Standard Deviation 3.85 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 4 hours | -8.8 Beats per minute | Standard Deviation 3.21 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 2 hours | -9.6 Beats per minute | Standard Deviation 2.38 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 24 hours | -5.6 Beats per minute | Standard Deviation 6.19 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 5 hours | -2.5 Beats per minute | Standard Deviation 3.27 |
| Etrasimod 2 mg Mini Tablets in Applesauce | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 8 hours | -4.3 Beats per minute | Standard Deviation 3.63 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 8 hours | -5.9 Beats per minute | Standard Deviation 6.48 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 24 hours | -7.4 Beats per minute | Standard Deviation 7.38 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 4 hours | -11.0 Beats per minute | Standard Deviation 7.08 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 6 hours | -4.4 Beats per minute | Standard Deviation 6.33 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 3 hours | -12.1 Beats per minute | Standard Deviation 7.41 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 2 hours | -11.5 Beats per minute | Standard Deviation 6.55 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 1 hour | -6.9 Beats per minute | Standard Deviation 7.12 |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 5 hours | -5.1 Beats per minute | Standard Deviation 6.98 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 2 hours | -9.8 Beats per minute | Standard Deviation 4.51 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 3 hours | -10.1 Beats per minute | Standard Deviation 5.07 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 4 hours | -8.7 Beats per minute | Standard Deviation 4.32 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 5 hours | -2.3 Beats per minute | Standard Deviation 4.27 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 6 hours | -3.1 Beats per minute | Standard Deviation 3.61 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 24 hours | -6.8 Beats per minute | Standard Deviation 4.62 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 1 hour | -3.9 Beats per minute | Standard Deviation 3.75 |
| Etrasimod 2 mg Mini Tablets in Water | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 8 hours | -4.9 Beats per minute | Standard Deviation 6.1 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 4 hours | -11.0 Beats per minute | Standard Deviation 3.85 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 24 hours | -6.8 Beats per minute | Standard Deviation 5.8 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 3 hours | -10.3 Beats per minute | Standard Deviation 4.39 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 8 hours | -3.8 Beats per minute | Standard Deviation 7.99 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 1 hour | -5.1 Beats per minute | Standard Deviation 4.32 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 6 hours | -2.6 Beats per minute | Standard Deviation 3.88 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 2 hours | -10.5 Beats per minute | Standard Deviation 4.62 |
| Etrasimod 2 mg Mini Tablets in Yogurt | Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 | At 5 hours | -4.4 Beats per minute | Standard Deviation 4.46 |
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.
Time frame: Up to Day 45
Population: SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 30 <= Change <= 60 | 1 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 450 < Value <= 480 | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Change > 60 | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 480 < Value <= 500 | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Value > 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 30 <= Change <= 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Value > 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 480 < Value <= 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Change > 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 450 < Value <= 480 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Value > 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 450 < Value <= 480 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 480 < Value <= 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 30 <= Change <= 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Change > 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Change > 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 450 < Value <= 480 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 30 <= Change <= 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Value > 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 480 < Value <= 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Value > 500 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 30 <= Change <= 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 450 < Value <= 480 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): Change > 60 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings | QTcF interval aggregate (Msec): 480 < Value <= 500 | 0 Participants |
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.
Time frame: Up to Day 45
Population: SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value <40 | 0 Participants |
| Etrasimod 2 mg IR Tablet | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value >120 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value <40 | 1 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value <90 | 2 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value >120 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value <90 | 1 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value >120 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value <40 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease | 3 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value >120 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase | 1 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value <90 | 1 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value <40 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase | 1 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value <40 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value <90 | 1 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Pulse Rate (beats/min) Value >120 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease | 0 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants According to Categorization of Vital Signs Results | Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease | 0 Participants |
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.
Time frame: Up to Day 45
Population: SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etrasimod 2 mg IR Tablet | Number of Participants With Clinical Laboratory Abnormalities | 5 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants With Clinical Laboratory Abnormalities | 10 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants With Clinical Laboratory Abnormalities | 8 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants With Clinical Laboratory Abnormalities | 5 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants With Clinical Laboratory Abnormalities | 6 Participants |
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.
Time frame: From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Population: SAS included all participants who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Etrasimod 2 mg IR Tablet | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 7 Participants |
| Etrasimod 2 mg Mini Tablets in Applesauce | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 10 Participants |
| Etrasimod 2 mg Mini Tablets in Chocolate Pudding | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 9 Participants |
| Etrasimod 2 mg Mini Tablets in Water | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 8 Participants |
| Etrasimod 2 mg Mini Tablets in Yogurt | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 11 Participants |