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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Belgium
  • Brussel, Belgium, 1070
    • Brussels Clinical Research Unit
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: bioavailability; etrasimod; adullt
• Other Study ID Numbers: C5041034; 2023-504411-32-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No