A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants

NCT05956002 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: C50410342023-504411-32-00
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare how healthy adults process Etrasimod when taken in different forms. One form is Etrasimod taken without food. The other form is Etrasimod mixed with water and 3 different foods. The types of food used are applesauce, chocolate pudding or yogurt. 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 2.5 months, including the screening period. Participants will have to stay at the study clinic for at least 45 days. This includes 5 study periods in total. Participants will take Etrasimod as a tablet by mouth without food. Participants will also take Etrasimod sprinkled in soft food or water. Blood samples will be taken both before and after participants take Etrasimod. Participants will also answer questions for taste assessment purposes. A follow-up phone call will be made 20 to 27 days after the last study period.

Conditions

Healthy Participants

Keywords

bioavailability; etrasimod; adult

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod

  AUClast was calculated using linear/log trapezoidal method.

  At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period

• Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod

  AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve.

  At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period

• Maximum Observed Plasma Concentration (Cmax) for Etrasimod

  At pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period

Secondary Outcomes (10)

• Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1

  Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)

• Number of Participants With Clinical Laboratory Abnormalities

  Up to Day 45

• Number of Participants According to Categorization of Vital Signs Results

  Up to Day 45

• Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings

  Up to Day 45

Study Arms (4)

Sequence 1

EXPERIMENTAL

Single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)

Drug: Estraimod Immediate Release (IR); Drug: Etrasimod Mini Tab in water; Drug: Etrasimod Mini Tab in chocolate pudding; Drug: Etrasimod Mini Tab in yogurt; Drug: Etrasimod Mini Tab in applesauce

Sequence 2

EXPERIMENTAL

Single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3) followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference) followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2) followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)

Drug: Estraimod Immediate Release (IR); Drug: Etrasimod Mini Tab in water; Drug: Etrasimod Mini Tab in chocolate pudding; Drug: Etrasimod Mini Tab in yogurt; Drug: Etrasimod Mini Tab in applesauce

Sequence 3

EXPERIMENTAL

Single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference).followed by single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1) Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)

Drug: Estraimod Immediate Release (IR); Drug: Etrasimod Mini Tab in water; Drug: Etrasimod Mini Tab in chocolate pudding; Drug: Etrasimod Mini Tab in yogurt; Drug: Etrasimod Mini Tab in applesauce

Sequence 4

EXPERIMENTAL

Single oral dose of etrasimod 2 mg mini tablets mixed with water under fasted conditions (Test 3). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with chocolate pudding under fasted conditions (Test 2). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with applesauce under fasted conditions (Test 1). Followed by single oral dose of etrasimod 2 mg clinical IR tablet under fasted conditions (Reference). Followed by single oral dose of etrasimod 2 mg mini tablets mixed with yogurt under fasted conditions (Test 4)

Drug: Estraimod Immediate Release (IR); Drug: Etrasimod Mini Tab in water; Drug: Etrasimod Mini Tab in chocolate pudding; Drug: Etrasimod Mini Tab in yogurt; Drug: Etrasimod Mini Tab in applesauce

Interventions

Estraimod Immediate Release (IR) DRUG

an immediate release tablet

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Etrasimod Mini Tab in water DRUG

very small tablet mixed in water

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Etrasimod Mini Tab in chocolate pudding DRUG

very small tablet mixed in chocolate pudding

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Etrasimod Mini Tab in yogurt DRUG

Very small tablet mixed in yogurt

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Etrasimod Mini Tab in applesauce DRUG

Very small tablet mixed in applesauce

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants
• BMI 16 to 32 kg/m2
• body weight more than 50kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Limitations and Caveats

Any untoward findings identified on physical examination during the active collection period were captured as adverse events, if those findings met the definition of an AE.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 21, 2023
• Study Start: September 4, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)