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Trial Outcomes & Findings for A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants (NCT NCT05956002)

NCT ID: NCT05956002

Last Updated: 2025-02-10

Results Overview

AUClast was calculated using linear/log trapezoidal method.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

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

Results posted on

2025-02-10

Participant Flow

A total of 16 participants were enrolled in this study.

All participants received at least one dose of etrasimod prepared in different vehicles.

Participant milestones

Participant milestones
Measure
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.
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.
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.
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.
Washout Period
COMPLETED
4
4
3
4
Washout Period
NOT COMPLETED
0
0
0
0
Treatment Period 5
STARTED
4
4
4
4
Treatment Period 5
COMPLETED
4
4
4
4
Treatment Period 5
NOT COMPLETED
0
0
0
0
Treatment Period 1
STARTED
4
4
4
4
Treatment Period 1
COMPLETED
4
4
4
4
Treatment Period 1
NOT COMPLETED
0
0
0
0
Washout Period
STARTED
4
4
3
4
Treatment Period 2
STARTED
4
4
4
4
Treatment Period 2
COMPLETED
4
4
4
4
Treatment Period 2
NOT COMPLETED
0
0
0
0
Treatment Period 3
STARTED
4
4
4
4
Treatment Period 3
COMPLETED
4
4
3
4
Treatment Period 3
NOT COMPLETED
0
0
1
0
Treatment Period 4
STARTED
4
4
3
4
Treatment Period 4
COMPLETED
4
4
3
4
Treatment Period 4
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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.
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.
Treatment Period 3
Adverse Event
0
0
1
0

Baseline Characteristics

A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=16 Participants
All participants who were randomized to receive any of the treatment sequence in any of the period were included.
Age, Continuous
42.1 Years
STANDARD_DEVIATION 11.27 • n=99 Participants
Sex: Female, Male
Female
5 Participants
n=99 Participants
Sex: Female, Male
Male
11 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
Race (NIH/OMB)
White
11 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants

PRIMARY outcome

Timeframe: 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.

AUClast was calculated using linear/log trapezoidal method.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
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
1529 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
1538 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
1391 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
1510 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod
1694 ng*hr/mL
Geometric Coefficient of Variation 26
1594 ng*hr/mL
Geometric Coefficient of Variation 20
1605 ng*hr/mL
Geometric Coefficient of Variation 19
1447 ng*hr/mL
Geometric Coefficient of Variation 23
1580 ng*hr/mL
Geometric Coefficient of Variation 22

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
Maximum Observed Plasma Concentration (Cmax) for Etrasimod
43.18 Nanogram per milliliter
Geometric Coefficient of Variation 22
40.44 Nanogram per milliliter
Geometric Coefficient of Variation 19
40.03 Nanogram per milliliter
Geometric Coefficient of Variation 18
37.67 Nanogram per milliliter
Geometric Coefficient of Variation 18
39.98 Nanogram per milliliter
Geometric Coefficient of Variation 21

SECONDARY outcome

Timeframe: 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.

Heart rate was measured in beats per minute.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
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
-4.3 Beats per minute
Standard Deviation 3.63
-5.9 Beats per minute
Standard Deviation 6.48
-4.9 Beats per minute
Standard Deviation 6.10
-3.8 Beats per minute
Standard Deviation 7.99
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
-5.6 Beats per minute
Standard Deviation 6.19
-7.4 Beats per minute
Standard Deviation 7.38
-6.8 Beats per minute
Standard Deviation 4.62
-6.8 Beats per minute
Standard Deviation 5.80
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
-6.0 Beats per minute
Standard Deviation 3.85
-6.9 Beats per minute
Standard Deviation 7.12
-3.9 Beats per minute
Standard Deviation 3.75
-5.1 Beats per minute
Standard Deviation 4.32
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
-9.6 Beats per minute
Standard Deviation 2.38
-11.5 Beats per minute
Standard Deviation 6.55
-9.8 Beats per minute
Standard Deviation 4.51
-10.5 Beats per minute
Standard Deviation 4.62
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 4.60
-9.9 Beats per minute
Standard Deviation 2.97
-12.1 Beats per minute
Standard Deviation 7.41
-10.1 Beats per minute
Standard Deviation 5.07
-10.3 Beats per minute
Standard Deviation 4.39
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
-8.8 Beats per minute
Standard Deviation 3.21
-11.0 Beats per minute
Standard Deviation 7.08
-8.7 Beats per minute
Standard Deviation 4.32
-11.0 Beats per minute
Standard Deviation 3.85
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
-2.5 Beats per minute
Standard Deviation 3.27
-5.1 Beats per minute
Standard Deviation 6.98
-2.3 Beats per minute
Standard Deviation 4.27
-4.4 Beats per minute
Standard Deviation 4.46
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
-2.0 Beats per minute
Standard Deviation 3.96
-4.4 Beats per minute
Standard Deviation 6.33
-3.1 Beats per minute
Standard Deviation 3.61
-2.6 Beats per minute
Standard Deviation 3.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
7 Participants
10 Participants
9 Participants
8 Participants
11 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
Number of Participants With Clinical Laboratory Abnormalities
5 Participants
10 Participants
8 Participants
5 Participants
6 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
Number of Participants According to Categorization of Vital Signs Results
Supine Diastolic Blood Pressure (mmHg) Value <50
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Systolic Blood Pressure (mmHg) Value <90
0 Participants
2 Participants
1 Participants
1 Participants
1 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Systolic Blood Pressure (mmHg) Value Change >= 30 Increase
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Systolic Blood Pressure (mmHg) Value Change >= 30 decrease
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Diastolic Blood Pressure (mmHg) Value >= 20 increase
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Diastolic Blood Pressure (mmHg) Value >= 20 decrease
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Pulse Rate (beats/min) Value <40
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Vital Signs Results
Supine Pulse Rate (beats/min) Value >120
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 Participants
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.
Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
QTcF interval aggregate (Msec): 450 < Value <= 480
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
QTcF interval aggregate (Msec): 480 < Value <= 500
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
QTcF interval aggregate (Msec): Value > 500
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
QTcF interval aggregate (Msec): 30 <= Change <= 60
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
QTcF interval aggregate (Msec): Change > 60
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
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.
Assessment of Mouth Feel Based on Palatability Questionnaire
At 20 minutes
7.0 Score on a scale
Standard Deviation 14.59
5.6 Score on a scale
Standard Deviation 5.23
8.8 Score on a scale
Standard Deviation 16.22
4.8 Score on a scale
Standard Deviation 6.61
—
Assessment of Mouth Feel Based on Palatability Questionnaire
At 1 minute
8.0 Score on a scale
Standard Deviation 10.34
5.0 Score on a scale
Standard Deviation 7.21
9.6 Score on a scale
Standard Deviation 17.14
9.3 Score on a scale
Standard Deviation 10.03
—
Assessment of Mouth Feel Based on Palatability Questionnaire
At 5 minutes
6.9 Score on a scale
Standard Deviation 9.93
4.7 Score on a scale
Standard Deviation 5.36
8.1 Score on a scale
Standard Deviation 15.84
8.4 Score on a scale
Standard Deviation 12.46
—
Assessment of Mouth Feel Based on Palatability Questionnaire
At 10 minutes
5.6 Score on a scale
Standard Deviation 10.27
6.6 Score on a scale
Standard Deviation 7.12
8.9 Score on a scale
Standard Deviation 18.04
7.4 Score on a scale
Standard Deviation 9.16
—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
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.
Assessment of Bitterness Based on Palatability Questionnaire
At 20 minutes
3.5 Score on a scale
Standard Deviation 3.91
4.2 Score on a scale
Standard Deviation 4.65
9.3 Score on a scale
Standard Deviation 17.50
4.3 Score on a scale
Standard Deviation 5.49
—
Assessment of Bitterness Based on Palatability Questionnaire
At 1 minute
12.3 Score on a scale
Standard Deviation 17.26
4.3 Score on a scale
Standard Deviation 5.69
9.4 Score on a scale
Standard Deviation 17.02
8.9 Score on a scale
Standard Deviation 15.09
—
Assessment of Bitterness Based on Palatability Questionnaire
At 5 minutes
5.0 Score on a scale
Standard Deviation 7.41
4.1 Score on a scale
Standard Deviation 4.92
8.3 Score on a scale
Standard Deviation 16.07
7.9 Score on a scale
Standard Deviation 12.39
—
Assessment of Bitterness Based on Palatability Questionnaire
At 10 minutes
4.2 Score on a scale
Standard Deviation 4.86
5.5 Score on a scale
Standard Deviation 6.53
9.9 Score on a scale
Standard Deviation 18.52
7.8 Score on a scale
Standard Deviation 11.49
—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
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.
Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire
At 1 minute
3.4 Score on a scale
Standard Deviation 3.81
2.7 Score on a scale
Standard Deviation 3.48
3.9 Score on a scale
Standard Deviation 4.04
4.8 Score on a scale
Standard Deviation 5.26
—
Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire
At 5 minutes
3.1 Score on a scale
Standard Deviation 3.76
3.1 Score on a scale
Standard Deviation 3.26
3.8 Score on a scale
Standard Deviation 3.34
3.4 Score on a scale
Standard Deviation 4.26
—
Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire
At 10 minutes
3.0 Score on a scale
Standard Deviation 3.80
3.6 Score on a scale
Standard Deviation 3.44
4.2 Score on a scale
Standard Deviation 3.36
3.6 Score on a scale
Standard Deviation 4.10
—
Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire
At 20 minutes
3.1 Score on a scale
Standard Deviation 3.56
4.3 Score on a scale
Standard Deviation 4.44
7.1 Score on a scale
Standard Deviation 10.16
3.0 Score on a scale
Standard Deviation 2.63
—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
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.
Assessment of Likeness of Throat Burn Based on Palatability Questionnaire
At 5 minutes
6.6 Score on a scale
Standard Deviation 12.16
3.6 Score on a scale
Standard Deviation 3.67
3.7 Score on a scale
Standard Deviation 3.46
6.8 Score on a scale
Standard Deviation 12.03
—
Assessment of Likeness of Throat Burn Based on Palatability Questionnaire
At 1 minute
6.9 Score on a scale
Standard Deviation 13.48
3.4 Score on a scale
Standard Deviation 3.77
4.0 Score on a scale
Standard Deviation 4.35
5.3 Score on a scale
Standard Deviation 7.04
—
Assessment of Likeness of Throat Burn Based on Palatability Questionnaire
At 10 minutes
6.3 Score on a scale
Standard Deviation 12.12
5.3 Score on a scale
Standard Deviation 7.04
10.2 Score on a scale
Standard Deviation 18.69
8.1 Score on a scale
Standard Deviation 17.98
—
Assessment of Likeness of Throat Burn Based on Palatability Questionnaire
At 20 minutes
6.2 Score on a scale
Standard Deviation 12.32
3.6 Score on a scale
Standard Deviation 3.95
13.6 Score on a scale
Standard Deviation 25.19
8.8 Score on a scale
Standard Deviation 17.28
—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Etrasimod 2 mg IR Tablet
n=15 Participants
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 Participants
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 Participants
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.
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.
Assessment of Overall Liking Based on Palatability Questionnaire
At 1 minute
8.9 Score on a scale
Standard Deviation 13.58
3.8 Score on a scale
Standard Deviation 4.90
8.1 Score on a scale
Standard Deviation 16.69
10.4 Score on a scale
Standard Deviation 14.24
—
Assessment of Overall Liking Based on Palatability Questionnaire
At 5 minutes
6.8 Score on a scale
Standard Deviation 12.20
4.4 Score on a scale
Standard Deviation 3.76
7.9 Score on a scale
Standard Deviation 16.55
10.1 Score on a scale
Standard Deviation 16.62
—
Assessment of Overall Liking Based on Palatability Questionnaire
At 10 minutes
6.5 Score on a scale
Standard Deviation 12.25
5.4 Score on a scale
Standard Deviation 4.78
9.2 Score on a scale
Standard Deviation 19.10
10.1 Score on a scale
Standard Deviation 18.64
—
Assessment of Overall Liking Based on Palatability Questionnaire
At 20 minutes
6.6 Score on a scale
Standard Deviation 12.55
4.3 Score on a scale
Standard Deviation 4.01
9.2 Score on a scale
Standard Deviation 17.70
9.8 Score on a scale
Standard Deviation 16.31
—

Adverse Events

Etrasimod 2 mg IR Tablet

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Etrasimod 2 mg Mini Tablets in Applesauce

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Etrasimod 2 mg Mini Tablets in Chocolate Pudding

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Etrasimod 2 mg Mini Tablets in Water

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Etrasimod 2 mg Mini Tablets in Yogurt

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Etrasimod 2 mg IR Tablet
n=16 participants at risk
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.
Etrasimod 2 mg Mini Tablets in Applesauce
n=15 participants at risk
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.
Etrasimod 2 mg Mini Tablets in Chocolate Pudding
n=16 participants at risk
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.
Etrasimod 2 mg Mini Tablets in Water
n=16 participants at risk
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.
Etrasimod 2 mg Mini Tablets in Yogurt
n=16 participants at risk
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.
Cardiac disorders
Atrioventricular block first degree
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Ear and labyrinth disorders
Ear pain
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Eye disorders
Asthenopia
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Eye disorders
Ocular hyperaemia
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Eye disorders
Photopsia
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Eye disorders
Vision blurred
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Abdominal pain
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Change of bowel habit
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Constipation
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Dyspepsia
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Glossodynia
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Lip dry
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Nausea
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Tongue ulceration
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Gastrointestinal disorders
Toothache
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
General disorders
Asthenia
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
General disorders
Fatigue
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
18.8%
3/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
General disorders
Influenza like illness
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
General disorders
Puncture site erythema
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
General disorders
Vessel puncture site erythema
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
General disorders
Vessel puncture site haematoma
18.8%
3/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Infections and infestations
Influenza
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Infections and infestations
Nasopharyngitis
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Infections and infestations
Oral herpes
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Injury, poisoning and procedural complications
Post procedural haematoma
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Injury, poisoning and procedural complications
Skin laceration
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Injury, poisoning and procedural complications
Sunburn
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Nervous system disorders
Burning sensation
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Nervous system disorders
Dizziness
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
25.0%
4/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Nervous system disorders
Dizziness postural
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Nervous system disorders
Dysgeusia
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Nervous system disorders
Headache
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
13.3%
2/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Nervous system disorders
Presyncope
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Respiratory, thoracic and mediastinal disorders
Nasal congestion
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
13.3%
2/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Acne
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
13.3%
2/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
12.5%
2/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.7%
1/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Rosacea
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Vascular disorders
Haematoma
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
Vascular disorders
Hot flush
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/15 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
0.00%
0/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
6.2%
1/16 • From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)

Additional Information

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Results disclosure agreements

  • Principal investigator is a sponsor employee 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.
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