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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Etrasimod Mini Tab in yogurt; Drug: Etrasimod Mini Tab in applesauce; Drug: Etrasimod Mini Tab in chocolate pudding; Drug: Etrasimod Mini Tab in water; Drug: Estraimod Immediate Release (IR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05956002

C5041034

2023-504411-32-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Sequence 1

Experimental group

Description:

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)

Treatment:

Drug: Estraimod Immediate Release (IR)

Drug: Etrasimod Mini Tab in chocolate pudding

Drug: Etrasimod Mini Tab in water

Drug: Etrasimod Mini Tab in applesauce

Drug: Etrasimod Mini Tab in yogurt

Sequence 2

Experimental group

Description:

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)

Treatment:

Drug: Estraimod Immediate Release (IR)

Drug: Etrasimod Mini Tab in chocolate pudding

Drug: Etrasimod Mini Tab in water

Drug: Etrasimod Mini Tab in applesauce

Drug: Etrasimod Mini Tab in yogurt

Sequence 3

Experimental group

Description:

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)

Treatment:

Drug: Estraimod Immediate Release (IR)

Drug: Etrasimod Mini Tab in chocolate pudding

Drug: Etrasimod Mini Tab in water

Drug: Etrasimod Mini Tab in applesauce

Drug: Etrasimod Mini Tab in yogurt

Sequence 4

Experimental group

Description:

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)

Treatment:

Drug: Estraimod Immediate Release (IR)

Drug: Etrasimod Mini Tab in chocolate pudding

Drug: Etrasimod Mini Tab in water

Drug: Etrasimod Mini Tab in applesauce

Drug: Etrasimod Mini Tab in yogurt