CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Estraimod Immediate Release (IR) +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05956002
NCT05956002Phase 1Completed

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

Pfizer·interventional·Posted Jul 21, 2023·Updated Feb 10, 2025

In Brief

A Phase 1 clinical trial evaluating Estraimod Immediate Release (IR), Etrasimod Mini Tab in water, and 3 other interventions for Healthy Participants. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedJul 21, 2023
Enrollment StartSep 4, 2023
Primary CompletionJan 4, 2024
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.9 years ago

Interventions

Estraimod Immediate Release (IR)drug

an immediate release tablet

Etrasimod Mini Tab in waterdrug

very small tablet mixed in water

Etrasimod Mini Tab in chocolate puddingdrug

very small tablet mixed in chocolate pudding

Etrasimod Mini Tab in yogurtdrug

Very small tablet mixed in yogurt

Etrasimod Mini Tab in applesaucedrug

Very small tablet mixed in applesauce