Trials / Completed
CompletedNCT05956002
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-09-04
- Primary completion
- 2024-01-04
- Completion
- 2024-01-04
- First posted
- 2023-07-21
- Last updated
- 2025-02-10
- Results posted
- 2025-02-10
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05956002. Inclusion in this directory is not an endorsement.