Phase 1 N=8 Basic Science

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

Healthy Participants

Bottom Line

View on ClinicalTrials.gov: NCT06140290 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling — 666.4; 745.5 Nanogram*hour per milliliter (ng*hr/mL )

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Etrasimod Immediate Release (IR) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling	666.4; 745.5	—
PRIMARY Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling	768.4; 872.1	—
PRIMARY Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling	1503; 1652	—
PRIMARY Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling	40.65; 44.63	—
SECONDARY AUC0-24 of Etrasimod: Tasso and Venous PK Sampling	666.4; 745.5; 725.8	—
SECONDARY AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling	768.4; 872.1; 890.1	—
SECONDARY AUCinf for Etrasimod: Tasso and Venous PK Sampling	1503; 1652; 1694	—
SECONDARY Cmax for Etrasimod: Tasso and Venous PK Sampling	40.65; 44.63; 43.18	—
SECONDARY Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1	-4.9; -3.4; -10.8; -10.3; -10.8; -10.9	—
SECONDARY Change From Baseline to Nadir in HR at Day 1	-14.1; -12.1	—
SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs)	7; 5	—
SECONDARY Number of Participants With Clinically Significant Findings in Laboratory Abnormalities	0; 0	—
SECONDARY Number of Participants With Clinically Significant Findings in Vital Signs	0; 0	—
SECONDARY Number of Participants With Clinically Significant Findings in Physical Examination	0; 0	—
SECONDARY Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria	1; 0; 0; 0; 0; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06140290). 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.