Clinical trial NCT05956002: A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: bioavailability
etrasimod
adult
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-07-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Etrasimod
timeFrame: 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
measure: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) for Etrasimod
timeFrame: 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:
measure: Change From Baseline in Heart Rate at 1, 2, 3, 4, 5, 6, 8 and 24 Hours on Day 1
timeFrame: Baseline, 1, 2, 3, 4, 5, 6, 8 and 24 hours post dose on Day 1
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days)
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to Day 45
measure: Number of Participants According to Categorization of Vital Signs Results
timeFrame: Up to Day 45
measure: Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
timeFrame: Up to Day 45
measure: Assessment of Mouth Feel Based on Palatability Questionnaire
timeFrame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
measure: Assessment of Bitterness Based on Palatability Questionnaire
timeFrame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
measure: Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire
timeFrame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
measure: Assessment of Likeness of Throat Burn Based on Palatability Questionnaire
timeFrame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
measure: Assessment of Overall Liking Based on Palatability Questionnaire
timeFrame: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: