C5041034 - 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

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504411-32-00

Acronym

C5041034

Enrollment

Registered

2023-06-12

Start date

2023-08-23

Completion date

2024-01-04

Last updated

2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alopecia areata, and eosinophilic esophagitis, atopic dermatitis, immune-mediated inflammatory disorders, including ulcerative colitis

Brief summary

Plasma AUClast, AUCinf and Cmax of etrasimod

Detailed description

Assessment of first dose HR reduction, TEAEs, clinical laboratory abnormalities, vital signs, PEs, and 12-lead ECGs, Assessment of palatability via questionnaire: mouth feel, bitterness, tongue/mouth burns, throat burn, and overall liking

Interventions

DRUGEtrasimod Arginine

DRUGEtrasimod Arginine Blue

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Plasma AUClast, AUCinf and Cmax of etrasimod	—

Secondary

Measure	Time frame
Assessment of first dose HR reduction, TEAEs, clinical laboratory abnormalities, vital signs, PEs, and 12-lead ECGs, Assessment of palatability via questionnaire: mouth feel, bitterness, tongue/mouth burns, throat burn, and overall liking	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026