A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Etrasimod Immediate Release (IR)

Registration Number: NCT06140290

Lead Sponsor: Pfizer

Brief Summary: The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.

The study is seeking participants who are:

* Aged 18 or older

* Male or female who are healthy as determined by medical assessment

* Body-mass index (BMI) of 16 to 32, and a total body weight \> 50kg.

The study will take up to 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods.

Participants will take Etrasimod as a tablet by mouth without food. Blood samples will be taken both before and after participants take Etrasimod. Participants will also use wearable devices to assess blood pressure, heart rate and take further blood samples. A follow-up phone call will be made 20 to 27 days after the last study period.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

Inclusion Criteria

Healthy participants
BMI 16 to 32 kg/m2
body weight more than 50kg

Exclusion Criteria

Ongoing or past history of significant medical conditions
Eye disorders such as macular edema or uveitis
Ongoing or recent infections
Use of prescription or non prescription medications within 7 days of first dose
Smoking or using nicotine products equivalent to more than 5 cigarettes per day
History of severe allergic or anaphylactic reactions

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fixed Sequence	Etrasimod Immediate Release (IR)	Single oral dose of etrasimod 2mg tablet under fasted conditions with site staff led assessments and training on how to use wearable sensors followed by single oral dose 2mg tablet under fasted conditions with participant led assessments with wearable sensors.

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling	Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period	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.
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	24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period	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.
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling	Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period	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.
Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling	Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period	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.

Secondary Outcome Measures

Name	Time	Method
AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling	24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period	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.
AUCinf for Etrasimod: Tasso and Venous PK Sampling	Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period	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.
Cmax for Etrasimod: Tasso and Venous PK Sampling	Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period	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.
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1	Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each period	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.
Change From Baseline to Nadir in HR at Day 1	Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each period	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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)	An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred 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.
Number of Participants With Clinically Significant Findings in Laboratory Abnormalities	Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)	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.
Number of Participants With Clinically Significant Findings in Vital Signs	Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)	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.
Number of Participants With Clinically Significant Findings in Physical Examination	Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)	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.
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria	From Baseline (Day 1) maximum up to Day 17	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.
AUC0-24 of Etrasimod: Tasso and Venous PK Sampling	Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period	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.