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Completed

NCT Number: NCT05956002

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estraimod Immediate Release (IR)

Drug

an immediate release tablet

Etrasimod Mini Tab in water

Drug

very small tablet mixed in water

Etrasimod Mini Tab in chocolate pudding

Drug

very small tablet mixed in chocolate pudding

Etrasimod Mini Tab in yogurt

Drug

Very small tablet mixed in yogurt

Etrasimod Mini Tab in applesauce

Drug

Very small tablet mixed in applesauce

Primary outcomes

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

    Time frame: 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

    AUClast was calculated using linear/log trapezoidal method.

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

    Time frame: 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

    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.

  3. Maximum Observed Plasma Concentration (Cmax) for Etrasimod

    Time frame: 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

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

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

    Heart rate was measured in beats per minute.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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

    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose, met one or more of the criteria: resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect. AEs included SAEs and all non-SAEs.

  3. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Up to Day 45

    Clinical laboratory abnormalities test criteria included haematology: lymphocytes (10^3/ mm^3) and lymphocytes/leukocytes percentage (%) less than (<) 0.8* lower limit of normal (LLN), neutrophils, eosinophils, monocytes (10^3/mm^3), eosinophils/leukocytes monocytes/leukocytes (%) more than (>) 1.2* upper limit of normal (ULN); clinical chemistry: bicarbonate milliequivalents per liter (mEq/L) > 1.1* ULN; Urinalysis: urine hemoglobin, nitrite, leukocyte esterase greater than or equal to (>=) 1 and squamous epithelial cells /low power field (/LPF) > 4. Number of participants meeting any clinical laboratory abnormalities criteria is reported in this outcome measure.

  4. Number of Participants According to Categorization of Vital Signs Results

    Time frame: Up to Day 45

    Supine blood pressure (SBP) and pulse rate (PR) were measured. Vital sign criteria included: Systolic BP: <90 millimeter of mercury [mmHg]; Systolic BP change from baseline: maximum increase and decrease >=30 mmHg; Diastolic BP < 50 mmHg; Diastolic BP change from baseline: maximum decrease and increase >=20 mmHg; pulse rate <40 and >120 beats per minute.

  5. Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings

    Time frame: Up to Day 45

    Standard 12-lead ECGs were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG abnormalities were categorized as: QTcF interval, aggregate (milliseconds [msec]) 450 < Value <= 480, 480 < value <= 500, value > 500; 30 <= Change <= 60; Change > 60. Participants with any ECG abnormality criteria were reported in this outcome measure.

  6. Assessment of Mouth Feel Based on Palatability Questionnaire

    Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period

    Participants were required to answer mouth feel (such as grittiness, stickiness, waxiness) of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse mouth feel.

  7. Assessment of Bitterness Based on Palatability Questionnaire

    Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period

    Participants were required to tell about the degree of bitterness of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated worse bitterness.

  8. Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire

    Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period

    Participants were required to tell about the degree of palatability attribute of tongue/mouth burns of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more tongue/mouth burns.

  9. Assessment of Likeness of Throat Burn Based on Palatability Questionnaire

    Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period

    Participants were required to tell the palatability attribute of throat burn of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated more throat burn.

  10. Assessment of Overall Liking Based on Palatability Questionnaire

    Time frame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period

    Participants were required to tell the palatability attribute of overall liking of the product tasted. The score ranged from 0 (favorable) to 100 (not favorable), where higher scores indicated less overall liking.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF ETRASIMOD (PF-07915503) MINI TABLETS IN WATER AND 3 FOOD VEHICLES COMPARED TO THE ETRASIMOD (PF-07915503) CLINICAL IR TABLETS UNDER FASTED CONDITIONS, AND TO EVALUATE MINI TABLET PALATABILITY IN HEALTHY ADULT PARTICIPANTS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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