Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Etrasimod Immediate Release · 1 trial · 1 indication
AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
| Arm | Type | Description |
|---|---|---|
| Fixed Sequence | EXPERIMENTAL | Single oral dose of etrasimod 2mg tablet under fasted conditions with site staff led assessments and training on how to use wearable sensors followed by single oral dose 2mg tablet under fasted conditions with participant led assessments with wearable sensors. |
| Name | Type | Description |
|---|---|---|
| Etrasimod Immediate Release (IR) | DRUG | An immediate release tablet |
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 me...
Etrasimod Immediate Release is an investigational small molecule being studied in healthy participants. It is not approved for any disease and is in early clinical development. The single completed Phase 1 trial enrolled healthy volunteers to evaluate the study medication using wearable sensors.
Etrasimod Immediate Release is being developed by Pfizer, Inc. (NYSE: PFE). The company sponsored a Phase 1 clinical trial of the drug in healthy participants.
Etrasimod Immediate Release is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The only trial listed for this asset is a completed Phase 1 study.
Etrasimod Immediate Release has one completed clinical trial, NCT06140290, titled "A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants." This Phase 1 study enrolled 8 participants in Belgium and was not randomized or blinded.
Etrasimod Immediate Release is a formulation of the drug etrasimod. The clinical trial NCT06140290 refers to the study medication as etrasimod, and the immediate release formulation is the specific version being evaluated in this Phase 1 study.