Phase 1
N=16
A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT05956002 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod — 1620; 1529; 1538; 1391 Nanogram*hour per milliliter (ng*hr/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 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 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod |
1620; 1529; 1538; 1391; 1510 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod |
1694; 1594; 1605; 1447; 1580 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for Etrasimod |
43.18; 40.44; 40.03; 37.67; 39.98 | — |
| SECONDARY Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1 |
-6.3; -6.0; -6.9; -3.9; -5.1; -10.4 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
7; 10; 9; 8; 11 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities |
5; 10; 8; 5; 6 | — |
| SECONDARY Number of Participants According to Categorization of Vital Signs Results |
0; 2; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Assessment of Mouth Feel Based on Palatability Questionnaire |
8.0; 5.0; 9.6; 9.3; 6.9; 4.7 | — |
| SECONDARY Assessment of Bitterness Based on Palatability Questionnaire |
12.3; 4.3; 9.4; 8.9; 5.0; 4.1 | — |
| SECONDARY Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire |
3.4; 2.7; 3.9; 4.8; 3.1; 3.1 | — |
| SECONDARY Assessment of Likeness of Throat Burn Based on Palatability Questionnaire |
6.9; 3.4; 4.0; 5.3; 6.6; 3.6 | — |
| SECONDARY Assessment of Overall Liking Based on Palatability Questionnaire |
8.9; 3.8; 8.1; 10.4; 6.8; 4.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05956002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.