A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
Study Details
Study Description
Brief Summary
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
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Male or female who are healthy as determined by medical assessment
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequence 1 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)
an immediate release tablet
Drug: Etrasimod Mini Tab in water
very small tablet mixed in water
Drug: Etrasimod Mini Tab in chocolate pudding
very small tablet mixed in chocolate pudding
Drug: Etrasimod Mini Tab in yogurt
Very small tablet mixed in yogurt
Drug: Etrasimod Mini Tab in applesauce
Very small tablet mixed in applesauce
|
| Experimental: Sequence 2 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)
an immediate release tablet
Drug: Etrasimod Mini Tab in water
very small tablet mixed in water
Drug: Etrasimod Mini Tab in chocolate pudding
very small tablet mixed in chocolate pudding
Drug: Etrasimod Mini Tab in yogurt
Very small tablet mixed in yogurt
Drug: Etrasimod Mini Tab in applesauce
Very small tablet mixed in applesauce
|
| Experimental: Sequence 3 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)
an immediate release tablet
Drug: Etrasimod Mini Tab in water
very small tablet mixed in water
Drug: Etrasimod Mini Tab in chocolate pudding
very small tablet mixed in chocolate pudding
Drug: Etrasimod Mini Tab in yogurt
Very small tablet mixed in yogurt
Drug: Etrasimod Mini Tab in applesauce
Very small tablet mixed in applesauce
|
| Experimental: Sequence 4 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)
an immediate release tablet
Drug: Etrasimod Mini Tab in water
very small tablet mixed in water
Drug: Etrasimod Mini Tab in chocolate pudding
very small tablet mixed in chocolate pudding
Drug: Etrasimod Mini Tab in yogurt
Very small tablet mixed in yogurt
Drug: Etrasimod Mini Tab in applesauce
Very small tablet mixed in applesauce
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 [minutes after dosing: 1, 5, 10, 20]
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.
- Mean degree of likeness of bitterness of mini tablets [minutes after dosing: 1, 5, 10, 20]
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.
- Mean degree of likeness of tongue/mouth burn of mini tablets [minutes after dosing: 1, 5, 10, 20]
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.
- Mean degree of likeness of throat burn of mini tablets [minutes after dosing: 1, 5, 10, 20]
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.
- Mean overall degree of likeness of mini tablets [minutes after dosing: 1, 5, 10, 20]
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.
Eligibility Criteria
Criteria
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
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Ongoing or recent infections
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Use of prescription or non prescription medications within 7 days of first dose
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Smoking or using nicotine products equivalent to more than 5 cigarettes per day
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History of severe allergic or anaphylactic reactions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brussels Clinical Research Unit | Brussel | Belgium | 1070 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C5041034
- 2023-504411-32-00