Trial Outcomes & Findings for A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants (NCT NCT06140290)
NCT ID: NCT06140290
Last Updated: 2025-03-24
Results Overview
AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
COMPLETED
PHASE1
8 participants
Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period
2025-03-24
Participant Flow
A total of 8 participants were enrolled in this present study.
For secondary pharmacokinetic (PK) outcome measures' analysis, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study \[NCT05956002\] is used for comparison. These participants were not enrolled in the present study C5041050 \[NCT06140290\], only the relevant historical data was used for comparison as per the objectives.
Participant milestones
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
Participants received a single oral dose of Etrasimod 2 milligram (mg) immediate release (IR) with 240 milliliter (mL) water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
|---|---|---|
|
Period 1
STARTED
|
8
|
0
|
|
Period 1
Treated
|
8
|
0
|
|
Period 1
COMPLETED
|
7
|
0
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
0
|
8
|
|
Period 2
Treated
|
0
|
7
|
|
Period 2
COMPLETED
|
0
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
Participants received a single oral dose of Etrasimod 2 milligram (mg) immediate release (IR) with 240 milliliter (mL) water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
|
Period 2
Assigned but not treated
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Participants: Etrasimod 2mg
n=8 Participants
All participants who received study treatment either in Period 1 or 2 of the study.
|
|---|---|
|
Age, Continuous
|
42.0 Years
STANDARD_DEVIATION 13.70 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 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
|
0 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
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each periodPopulation: 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.
AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling
|
666.4 Nanogram*hour per milliliter (ng*hr/mL )
Geometric Coefficient of Variation 23
|
745.5 Nanogram*hour per milliliter (ng*hr/mL )
Geometric Coefficient of Variation 25
|
—
|
PRIMARY outcome
Timeframe: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each periodPopulation: PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=6 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling
|
768.4 ng*hr/mL
Geometric Coefficient of Variation 37
|
872.1 ng*hr/mL
Geometric Coefficient of Variation 16
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each periodPopulation: PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=6 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling
|
1503 ng*hr/mL
Geometric Coefficient of Variation 32
|
1652 ng*hr/mL
Geometric Coefficient of Variation 19
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each periodPopulation: 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.
PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling
|
40.65 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26
|
44.63 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each periodPopulation: 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.
AUC0-24 was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
n=16 Participants
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
AUC0-24 of Etrasimod: Tasso and Venous PK Sampling
|
666.4 ng*hr/mL
Geometric Coefficient of Variation 23
|
745.5 ng*hr/mL
Geometric Coefficient of Variation 25
|
725.8 ng*hr/mL
Geometric Coefficient of Variation 21
|
SECONDARY outcome
Timeframe: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each periodPopulation: PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
AUC24hr-last was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=6 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
n=16 Participants
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling
|
768.4 ng*hr/mL
Geometric Coefficient of Variation 37
|
872.1 ng*hr/mL
Geometric Coefficient of Variation 16
|
890.1 ng*hr/mL
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each periodPopulation: PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=6 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
n=16 Participants
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
AUCinf for Etrasimod: Tasso and Venous PK Sampling
|
1503 ng*hr/mL
Geometric Coefficient of Variation 32
|
1652 ng*hr/mL
Geometric Coefficient of Variation 19
|
1694 ng*hr/mL
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each periodPopulation: 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.
PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
n=16 Participants
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Cmax for Etrasimod: Tasso and Venous PK Sampling
|
40.65 ng/mL
Geometric Coefficient of Variation 26
|
44.63 ng/mL
Geometric Coefficient of Variation 28
|
43.18 ng/mL
Geometric Coefficient of Variation 22
|
SECONDARY outcome
Timeframe: Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each periodPopulation: SAS included all participants who took at least 1 dose of study intervention.
Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate electrocardiogram (ECG) HR measurements collected at pre-dose (0 hour) on Day 1 of each period.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 4 hours
|
-10.8 Beats/minute
Standard Deviation 5.73
|
-10.1 Beats/minute
Standard Deviation 3.44
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 1 hour
|
-4.9 Beats/minute
Standard Deviation 3.56
|
-3.4 Beats/minute
Standard Deviation 1.72
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 2 hours
|
-10.8 Beats/minute
Standard Deviation 4.33
|
-10.3 Beats/minute
Standard Deviation 2.75
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 3 hours
|
-10.8 Beats/minute
Standard Deviation 5.44
|
-10.9 Beats/minute
Standard Deviation 2.34
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 5 hours
|
-4.6 Beats/minute
Standard Deviation 4.44
|
-2.4 Beats/minute
Standard Deviation 3.46
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 6 hours
|
-7.0 Beats/minute
Standard Deviation 5.58
|
-2.0 Beats/minute
Standard Deviation 5.92
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 8 hours
|
-9.0 Beats/minute
Standard Deviation 6.82
|
-4.9 Beats/minute
Standard Deviation 4.56
|
—
|
|
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Change at 24 hours
|
-8.4 Beats/minute
Standard Deviation 4.60
|
-1.9 Beats/minute
Standard Deviation 5.01
|
—
|
SECONDARY outcome
Timeframe: Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each periodPopulation: SAS included all participants who took at least 1 dose of study intervention.
Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate ECG HR measurements collected at pre-dose (0 hour) on Day 1 of each period. Nadir HR was taken as the minimum HR from all ECGs taken post-Etrasimod on day 1 of each period. If Nadir HR was attained at multiple post-dose time points on Day 1, only the latest time point was summarized.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Change From Baseline to Nadir in HR at Day 1
|
-14.1 Beats/ min
Standard Deviation 5.14
|
-12.1 Beats/ min
Standard Deviation 2.27
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)Population: SAS included all participants who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred on or after the first dose of study treatment up to 35 days post last dose of study treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
7 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)Population: SAS included all participants who took at least 1 dose of study intervention.
Clinical laboratory abnormalities test criteria included, a) hematology: lymphocytes (10\^3/millimeter \[mm)\^3\]) and lymphocytes/leukocytes percentage (%) less than (\<) 0.8\* lower limit of normal (LLN), eosinophils (10\^3/mm\^3), eosinophils/leukocytes (%) and monocytes (10\^3/mm\^3) greater than (\>)1.2\* upper limit of normal (ULN); b) Urinalysis: urine glucose, ketones, urine hemoglobin and bilirubin, leukocyte esterase greater than equal to (\>=) 1. Clinical significance of laboratory abnormalities was determined by the investigator.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)Population: SAS included all participants who took at least 1 dose of study intervention.
Vital signs included blood pressure systolic and diastolic millimeter of mercury (mmHg) and pulse rate (beats/min). Clinical significance of vital signs abnormalities was determined by the investigator.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Vital Signs
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)Population: SAS included all participants who took at least 1 dose of study intervention.
A complete physical examination test included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination test included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Clinical significance of physical examination abnormalities was determined by the investigator.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Findings in Physical Examination
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) maximum up to Day 17Population: SAS included all participants who took at least 1 dose of study intervention.
ECG findings criteria for QT interval corrected using Fridericia's formula (QTcF) were as: 450 millisecond (msec) \< value less than equal (\<=) 480 msec, 480 msec \< value \<=500 msec, \>500 msec, 30 msec \<= change from baseline \<=60 msec, change from baseline \>60 msec.
Outcome measures
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 Participants
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 Participants
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
Etrasimod 2mg IR Tablet: Treatment A, C5041034 Study
Participants who received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL of water on Day 1 of Period 1, 2, 3 or 4 under fasting conditions (Treatment A) in the study C5041034. Only the relevant historical data from these participants is utilized, they are not enrolled in the present study.
|
|---|---|---|---|
|
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
450 msec < Value <= 480 msec
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
480 msec < Value <= 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
Value > 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
30 msec <= Change from baseline <= 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
Change from baseline > 60 msec
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)
n=8 participants at risk
Participants received a single oral dose of Etrasimod 2 mg IR with 240 mL water under fasting conditions on Day 1 of Period 1 (Treatment F). Participant were given practice sessions on Tasso and wearable monitoring devices on Day 2.
|
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)
n=7 participants at risk
Participants received a single oral dose of Etrasimod 2 mg IR tablet with 240 mL water under fasting conditions on Day 1 of Period 2 (Treatment G). Participants were not given practice sessions on Tasso and wearable monitoring devices.
|
|---|---|---|
|
Cardiac disorders
Atrioventricular block first degree
|
25.0%
2/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
General disorders
Application site irritation
|
50.0%
4/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
General disorders
Influenza like illness
|
12.5%
1/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
General disorders
Puncture site injury
|
25.0%
2/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
12.5%
1/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
28.6%
2/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Product Issues
Device issue
|
0.00%
0/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
14.3%
1/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
12.5%
1/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
0.00%
0/7 • Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
SAS included all participants who took at least 1 dose of study intervention.
|
Additional Information
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.
- Publication restrictions are in place
Restriction type: OTHER