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

Study Overview
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Brief Summary
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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.

Official Title
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A PHASE 1, OPEN-LABEL, SINGLE DOSE, FIXED-SEQUENCE CROSSOVER SUB STUDY TO DETERMINE THE PHARMACOKINETICS USING TASSO DEVICE AND SAFETY AND TOLERABILITY USING WEARABLE MONITORING DEVICES FOLLOWING SINGLE ORAL DOSES OF ETRASIMOD 2 MG IR TABLETS IN HEALTHY ADULT PARTICIPANTS IN A HYBRID DECENTRALIZED CLINICAL TRIAL DESIGN

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Etrasimod Immediate Realease (IR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Sequence<br>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. | Drug: Etrasimod Immediate Realease (IR)<br>* an immediate release tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (24 hour) | PK micro samples | Hour 0, 1, 2, 4, 6, 8, 12 and 24 hours postdose | 
| Area under the curve (24 hour to last available) | PK micro samples | Hour 24, 48, 72, 96, 120, 144 and 168 hours postdose | 
| Area under the curve (infinity) if data permits otherwise Area under the curve (last) | PK micro samples | Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose | 
| Cmax (maximum observed concentration) | PK micro samples | Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (24 hour) | micro samples and venous samples | Hour 0, 1, 2, 4, 6, 8, 12 and 24 hours postdose | 
| Area under the curve (24 hours to last available) | micro samples and venous samples | Hour 24, 48, 72, 96, 120, 144 and 168 hours postdose | 
| Area under the curve (infinity) if data permits otherwise area under the curve (last) | micro samples and venous samples | Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose | 
| Cmax (maximum observed concentration) | micro samples and venous samples | Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose | 
| Number of participants with a clinically significant change from baseline heart rate |  | Hour 0-24 | 
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) |  | Baseline (Day 0) up to 35 days after last dose of study medication | 
| Number of Participants With clinically significant clinical laboratory abnormalities |  | Baseline (Day 0) up to 35 days after last dose of study medication | 
| Number of Participants With clinically significant vital signs change from baseline |  | Baseline (Day 0) up to 35 days after last dose of study medication | 
| Number of Participants With clinically significant physical exam changes from baseline |  | Baseline (Day 0) up to 35 days after last dose of study medication | 
| Number of Participants With clinically significant electrocardiogram changes from baseline |  | Baseline (Day 0) up to 35 days after last dose of study medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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etrasimod, adults