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

Study Overview
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Brief Summary
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The purpose of this study is to compare how healthy adults process Etrasimod when taken in different forms. One form is Etrasimod taken without food. The other form is Etrasimod mixed with water and 3 different foods. The types of food used are applesauce, chocolate pudding or yogurt. The study is seeking participants who are: Aged 18 or older Male or female who are healthy as determined by medical assessment Body-mass index (BMI) of 16 to 32, and a total body weight > 50kg. The study will take up to 2.5 months, including the screening period. Participants will have to stay at the study clinic for at least 45 days. This includes 5 study periods in total. Participants will take Etrasimod as a tablet by mouth without food. Participants will also take Etrasimod sprinkled in soft food or water. Blood samples will be taken both before and after participants take Etrasimod. Participants will also answer questions for taste assessment purposes. A follow-up phone call will be made 20 to 27 days after the last study period.

Official Title
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A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF ETRASIMOD (PF-07915503) MINI TABLETS IN WATER AND 3 FOOD VEHICLES COMPARED TO THE ETRASIMOD (PF-07915503) CLINICAL IR TABLETS UNDER FASTED CONDITIONS, AND TO EVALUATE MINI TABLET PALATABILITY IN HEALTHY ADULT PARTICIPANTS

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Estraimod Immediate Release (IR)
* Drug: Etrasimod Mini Tab in water
* Drug: Etrasimod Mini Tab in chocolate pudding
* Drug: Etrasimod Mini Tab in yogurt
* Drug: Etrasimod Mini Tab in applesauce


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) | Drug: Estraimod Immediate Release (IR)<br>* an immediate release tablet<br>Drug: Etrasimod Mini Tab in water<br>* very small tablet mixed in water<br>Drug: Etrasimod Mini Tab in chocolate pudding<br>* very small tablet mixed in chocolate pudding<br>Drug: Etrasimod Mini Tab in yogurt<br>* Very small tablet mixed in yogurt<br>Drug: Etrasimod Mini Tab in applesauce<br>* Very small tablet mixed in applesauce<br>|
| Experimental: Sequence 2<br>Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) | Drug: Estraimod Immediate Release (IR)<br>* an immediate release tablet<br>Drug: Etrasimod Mini Tab in water<br>* very small tablet mixed in water<br>Drug: Etrasimod Mini Tab in chocolate pudding<br>* very small tablet mixed in chocolate pudding<br>Drug: Etrasimod Mini Tab in yogurt<br>* Very small tablet mixed in yogurt<br>Drug: Etrasimod Mini Tab in applesauce<br>* Very small tablet mixed in applesauce<br>|
| Experimental: Sequence 3<br>Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) | Drug: Estraimod Immediate Release (IR)<br>* an immediate release tablet<br>Drug: Etrasimod Mini Tab in water<br>* very small tablet mixed in water<br>Drug: Etrasimod Mini Tab in chocolate pudding<br>* very small tablet mixed in chocolate pudding<br>Drug: Etrasimod Mini Tab in yogurt<br>* Very small tablet mixed in yogurt<br>Drug: Etrasimod Mini Tab in applesauce<br>* Very small tablet mixed in applesauce<br>|
| Experimental: Sequence 4<br>Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4) | Drug: Estraimod Immediate Release (IR)<br>* an immediate release tablet<br>Drug: Etrasimod Mini Tab in water<br>* very small tablet mixed in water<br>Drug: Etrasimod Mini Tab in chocolate pudding<br>* very small tablet mixed in chocolate pudding<br>Drug: Etrasimod Mini Tab in yogurt<br>* Very small tablet mixed in yogurt<br>Drug: Etrasimod Mini Tab in applesauce<br>* Very small tablet mixed in applesauce<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (last) |  | Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose | 
| Area under the curve (infinity) |  | Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose | 
| Cmax (maximum observed concentration) |  | 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 |
| --- | --- | --- |
| 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 65 days after last dose of study medication | 
| Number of Participants With clinically significant clinical laboratory abnormalities |  | Baseline (Day 0) up to 65 days after last dose of study medication | 
| Number of Participants With clinically significant vital signs change from baseline |  | Baseline (Day 0) up to 65 days after last dose of study medication | 
| Number of Participants With clinically significant physical exam changes from baseline |  | Baseline (Day 0) up to 65 days after last dose of study medication | 
| Number of Participants With clinically significant electrocardiogram changes from baseline |  | Baseline (Day 0) up to 65 days after last dose of study medication | 
| Mean degree of likeness of mouth feel of mini tablets | Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire. | minutes after dosing: 1, 5, 10, 20 | 
| Mean degree of likeness of bitterness of mini tablets | Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire. | minutes after dosing: 1, 5, 10, 20 | 
| Mean degree of likeness of tongue/mouth burn of mini tablets | Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire. | minutes after dosing: 1, 5, 10, 20 | 
| Mean degree of likeness of throat burn of mini tablets | Throat burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire. | minutes after dosing: 1, 5, 10, 20 | 
| Mean overall degree of likeness of mini tablets | Overall likeness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire. | minutes after dosing: 1, 5, 10, 20 | 

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