Healthy ParticipantsPhase 1NCT05956002

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

A Phase 1 study testing Estraimod Immediate Release (IR), Etrasimod Mini Tab in water and Etrasimod Mini Tab in chocolate pudding in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Estraimod Immediate Release (IR), Etrasimod Mini Tab in water and Etrasimod Mini Tab in chocolate pudding
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteBelgium
Study dates: 4 Sep 2023to 4 Jan 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

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

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
Being tested: Estraimod Immediate Release (IR), Etrasimod Mini Tab in water, Etrasimod Mini Tab in chocolate pudding, Etrasimod Mini Tab in yogurt, Etrasimod Mini Tab in applesauce
Keywords: bioavailability, etrasimod, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Estraimod Immediate Release (IR)Drug
an immediate release tablet
Etrasimod Mini Tab in waterDrug
very small tablet mixed in water
Etrasimod Mini Tab in chocolate puddingDrug
very small tablet mixed in chocolate pudding
Etrasimod Mini Tab in yogurtDrug
Very small tablet mixed in yogurt
Etrasimod Mini Tab in applesauceDrug
Very small tablet mixed in applesauce

Study groups in NCT05956002
Study group	Role	What they receive
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) Receives: 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) Receives: 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) Receives: 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) Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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
Heart rate was measured in beats per minute.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Assessment of Bitterness Based on Palatability Questionnaire
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.
Measured: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Assessment of Tongue/Mouth Burns Based on Palatability Questionnaire
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.
Measured: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Assessment of Likeness of Throat Burn Based on Palatability Questionnaire
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.
Measured: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period
Assessment of Overall Liking Based on Palatability Questionnaire
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.
Measured: At 1, 5, 10 and 20 minutes after tasting dose in each vehicle on Day 1 of each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 20234 Jan 2024

First posted21 Jul 2023
Study start4 Sep 2023
Primary completion4 Jan 2024
Study completion4 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05956002
Sponsor's protocol ID: C5041034
Other IDs: 2023-504411-32-00, 2023
Status last verified: Feb 2025
First submitted: 29 Jun 2023
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05956002
Acronym / sponsor ID: C5041034
Conditions: Healthy Participants
Keywords: bioavailability, etrasimod, adult
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 4 Sep 2023 (actual)
Primary completion: 4 Jan 2024 (actual)
Study completion: 4 Jan 2024 (actual)
First posted: 21 Jul 2023 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence 1	Experimental	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 applesauceSingle 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)
Sequence 2	Experimental	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 applesauceSingle 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)
Sequence 3	Experimental	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 applesauceSingle 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)
Sequence 4	Experimental	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 applesauceSingle 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Estraimod Immediate Release (IR)an immediate release tablet	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
Etrasimod Mini Tab in watervery small tablet mixed in water	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
Etrasimod Mini Tab in chocolate puddingvery small tablet mixed in chocolate pudding	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
Etrasimod Mini Tab in yogurtVery small tablet mixed in yogurt	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4
Etrasimod Mini Tab in applesauceVery small tablet mixed in applesauce	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4

Primary outcome

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.
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.
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

10 secondary outcomes

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
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)
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Up to Day 45
Number of Participants According to Categorization of Vital Signs Results
Time frame: Up to Day 45
Number of Participants According to Categorization of Electrocardiograms (ECGs) Findings
Time frame: Up to Day 45
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
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
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
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
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

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence: A Then B Then C Then D Then E	4	4
Treatment Sequence: B Then D Then A Then C Then E	4	4
Treatment Sequence: C Then A Then D Then B Then E	4	4
Treatment Sequence: D Then C Then B Then A Then E	4	4

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram*hour per milliliter (ng*hr/mL)

Measure	Etrasimod 2 mg IR Tablet n = 16	Etrasimod 2 mg Mini Tablets in Applesauce n = 15	Etrasimod 2 mg Mini Tablets in Chocolate Pudding n = 16	Etrasimod 2 mg Mini Tablets in Water n = 16	Etrasimod 2 mg Mini Tablets in Yogurt n = 16
Value	1620 (26)	1529 (19)	1538 (19)	1391 (22)	1510 (22)

Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Applesauce: Ratio of adjusted geometric means: 94.66 (90% CI 91.33 to 98.12)
Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Chocolate Pudding: Ratio of adjusted geometric means: 94.96 (90% CI 91.69 to 98.34)
Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Water: Ratio of adjusted geometric means: 85.86 (90% CI 82.90 to 88.92)

Population analysed: Pharmacokinetic (PK) parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Etrasimod 2 mg IR Tablet n = 16	Etrasimod 2 mg Mini Tablets in Applesauce n = 15	Etrasimod 2 mg Mini Tablets in Chocolate Pudding n = 16	Etrasimod 2 mg Mini Tablets in Water n = 16	Etrasimod 2 mg Mini Tablets in Yogurt n = 16
Value	1694 (26)	1594 (20)	1605 (19)	1447 (23)	1580 (22)

Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Applesauce: Ratio of adjusted geometric means: 94.36 (90% CI 90.97 to 97.89)
Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Chocolate Pudding: Ratio of adjusted geometric means: 94.75 (90% CI 91.41 to 98.20)
Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Water: Ratio of adjusted geometric means: 85.44 (90% CI 82.43 to 88.55)

Population analysed: PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for Etrasimod

Measure	Etrasimod 2 mg IR Tablet n = 16	Etrasimod 2 mg Mini Tablets in Applesauce n = 15	Etrasimod 2 mg Mini Tablets in Chocolate Pudding n = 16	Etrasimod 2 mg Mini Tablets in Water n = 16	Etrasimod 2 mg Mini Tablets in Yogurt n = 16
Value	43.18 (22)	40.44 (19)	40.03 (18)	37.67 (18)	39.98 (21)

Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Applesauce: Ratio of adjusted geometric means: 94.70 (90% CI 90.38 to 99.22)
Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Chocolate Pudding: Ratio of adjusted geometric means: 92.72 (90% CI 88.59 to 97.04)
Etrasimod 2 mg IR Tablet vs Etrasimod 2 mg Mini Tablets in Water: Ratio of adjusted geometric means: 87.24 (90% CI 83.35 to 91.31)

Population analysed: PK parameter analysis set included all participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study treatment up to 28-35 days after last dose of study treatment (maximum up to 72 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etrasimod 2 mg IR Tablet	0 of 16 (0%)	7 of 16 (43.8%)	0 of 16
Etrasimod 2 mg Mini Tablets in Applesauce	0 of 15 (0%)	10 of 15 (66.7%)	0 of 15
Etrasimod 2 mg Mini Tablets in Chocolate Pudding	0 of 16 (0%)	9 of 16 (56.3%)	0 of 16
Etrasimod 2 mg Mini Tablets in Water	0 of 16 (0%)	8 of 16 (50%)	0 of 16
Etrasimod 2 mg Mini Tablets in Yogurt	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05956002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.