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

NCT05956002 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-10

Study results available
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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
* 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.

Conditions

  • Healthy Participants

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-04
Primary Completion
2024-01-04
Completion
2024-01-04
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956002 on ClinicalTrials.gov