NCT06140290

A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants

A PHASE 1, OPEN-LABEL, SINGLE DOSE, FIXED-SEQUENCE CROSSOVER SUB STUDY TO DETERMINE THE PHARMACOKINETICS USING TASSO DEVICE AND SAFETY AND TOLERABILITY USING WEARABLE MONITORING DEVICES FOLLOWING SINGLE ORAL DOSES OF ETRASIMOD 2 MG IR TABLETS IN HEALTHY ADULT PARTICIPANTS IN A HYBRID DECENTRALIZED CLINICAL TRIAL DESIGN

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training. 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 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods. Participants will take Etrasimod as a tablet by mouth without food. Blood samples will be taken both before and after participants take Etrasimod. Participants will also use wearable devices to assess blood pressure, heart rate and take further blood samples. A follow-up phone call will be made 20 to 27 days after the last study period.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Etrasimod Immediate Release (IR)	An immediate release tablet

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-11-18
• Last updated: 2025-03-24
• Results posted: 2025-03-24

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study