Approval Probability
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Also known as Etrasimod Immediate Release (IR)
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 developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development. The immediate release designation distinguishes this formulation from other versions of etrasimod.
Etrasimod Immediate Release targets the sphingosine-1-phosphate receptors S1PR1, S1PR4, and S1PR5, where it acts as an agonist. This receptor activity is the basis for its investigational mechanism.
Etrasimod Immediate Release is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE.
Etrasimod Immediate Release is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication.
Etrasimod Immediate Release has been evaluated in one completed Phase 1 trial, NCT06140290, titled "A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants." The trial enrolled 8 healthy volunteers in Belgium.
Yes, Etrasimod Immediate Release is also known as Etrasimod Immediate Release (IR). The IR abbreviation stands for immediate release, referring to the same formulation.