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

Pfizer16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

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.

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

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

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

Heart rate was measured in beats per minute.

Time frame: 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)

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.

Time frame: 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

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.

Time frame: Up to Day 45

Number of Participants According to Categorization of Vital Signs Results

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.

Time frame: Up to Day 45

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

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.

Time frame: Up to Day 45

Assessment of Mouth Feel Based on Palatability Questionnaire

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.