Healthy ParticipantsPhase 1NCT06140290

A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants

A Phase 1 study testing Etrasimod Immediate Release (IR) 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 look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training. 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?: Etrasimod Immediate Release (IR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteBelgium
Study dates: 20 Dec 2023to 1 Mar 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, SINGLE DOSE, FIXED-SEQUENCE CROSSOVER SUB STUDY TO DETERMINE THE PHARMACOKINETICS USING TASSO DEVICE AND SAFETY AND TOLERABILITY USING WEARABLE MONITORING DEVICES FOLLOWING SINGLE ORAL DOSES OF ETRASIMOD 2 MG IR TABLETS IN HEALTHY ADULT PARTICIPANTS IN A HYBRID DECENTRALIZED CLINICAL TRIAL DESIGN

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 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods.

Participants will take Etrasimod as a tablet by mouth without food. Blood samples will be taken both before and after participants take Etrasimod. Participants will also use wearable devices to assess blood pressure, heart rate and take further blood samples. A follow-up phone call will be made 20 to 27 days after the last study period.

Conditions: Healthy Participants
Being tested: Etrasimod Immediate Release (IR)
Keywords: etrasimod, adults

What participants receive

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

Etrasimod Immediate Release (IR)Drug
An immediate release tablet

Study groups in NCT06140290
Study group	Role	What they receive
Fixed Sequence	Experimental	Single oral dose of etrasimod 2mg tablet under fasted conditions with site staff led assessments and training on how to use wearable sensors followed by single oral dose 2mg tablet under fasted conditions with participant led assessments with wearable sensors. Receives: Drug: Etrasimod Immediate Release (IR)

What is being measured

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

Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling
AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Measured: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period
Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling
AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Measured: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling
AUCinf was calculated as AUClast + (Clast*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Measured: Pre-dose (0 hour), 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 Concentration (Cmax) of Etrasimod: Tasso PK Sampling
PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Measured: Pre-dose (0 hour), 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 (11)

AUC0-24 of Etrasimod: Tasso and Venous PK Sampling
AUC0-24 was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Measured: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period
AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling
AUC24hr-last was calculated as linear/log trapezoidal method. In this outcome measure, as planned, data of participants who received Etrasimod 2 mg IR tablet (Treatment A) in C5041034 study is used for comparison. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely; c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Measured: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
AUCinf for Etrasimod: Tasso and Venous PK Sampling
AUCinf was calculated as AUClast + (Clast*/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Measured: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
Cmax for Etrasimod: Tasso and Venous PK Sampling
PK sampling: a) Treatment F/Test: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely. c) Treatment A/Reference: Venous PK sampling from pre-dose (0 hour) till 168 hours post-dose.
Measured: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate electrocardiogram (ECG) HR measurements collected at pre-dose (0 hour) on Day 1 of each period.
Measured: Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each period
Change From Baseline to Nadir in HR at Day 1
Heart rate was measured in beats per minute (beats/min). Baseline was defined as the average of triplicate ECG HR measurements collected at pre-dose (0 hour) on Day 1 of each period. Nadir HR was taken as the minimum HR from all ECGs taken post-Etrasimod on day 1 of each period. If Nadir HR was attained at multiple post-dose time points on Day 1, only the latest time point was summarized.
Measured: Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each period
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 on or after the first dose of study treatment up to 35 days post last dose of study treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect.
Measured: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants With Clinically Significant Findings in Laboratory Abnormalities
Clinical laboratory abnormalities test criteria included, a) hematology: lymphocytes (10^3/millimeter [mm)^3]) and lymphocytes/leukocytes percentage (%) less than (<) 0.8* lower limit of normal (LLN), eosinophils (10^3/mm^3), eosinophils/leukocytes (%) and monocytes (10^3/mm^3) greater than (>)1.2* upper limit of normal (ULN); b) Urinalysis: urine glucose, ketones, urine hemoglobin and bilirubin, leukocyte esterase greater than equal to (>=) 1. Clinical significance of laboratory abnormalities was determined by the investigator.
Measured: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants With Clinically Significant Findings in Vital Signs
Vital signs included blood pressure systolic and diastolic millimeter of mercury (mmHg) and pulse rate (beats/min). Clinical significance of vital signs abnormalities was determined by the investigator.
Measured: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants With Clinically Significant Findings in Physical Examination
A complete physical examination test included, at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination test included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant reported symptoms. Clinical significance of physical examination abnormalities was determined by the investigator.
Measured: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
ECG findings criteria for QT interval corrected using Fridericia's formula (QTcF) were as: 450 millisecond (msec) < value less than equal (<=) 480 msec, 480 msec < value <=500 msec, >500 msec, 30 msec <= change from baseline <=60 msec, change from baseline >60 msec.
Measured: From Baseline (Day 1) maximum up to Day 17

Timeline

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

20 Dec 20231 Mar 2024

First posted18 Nov 2023
Study start20 Dec 2023
Primary completion1 Mar 2024
Study completion1 Mar 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06140290
Sponsor's protocol ID: C5041050
Other IDs: C5041034 Sub-Study, 2023-508119-22-00, 2023
Status last verified: Feb 2025
First submitted: 15 Nov 2023
Last updated: 24 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
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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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, SINGLE DOSE, FIXED-SEQUENCE CROSSOVER SUB STUDY TO DETERMINE THE PHARMACOKINETICS USING TASSO DEVICE AND SAFETY AND TOLERABILITY USING WEARABLE MONITORING DEVICES FOLLOWING SINGLE ORAL DOSES OF ETRASIMOD 2 MG IR TABLETS IN HEALTHY ADULT PARTICIPANTS IN A HYBRID DECENTRALIZED CLINICAL TRIAL DESIGN
ClinicalTrials.gov ID: NCT06140290
Acronym / sponsor ID: C5041050
Conditions: Healthy Participants
Keywords: etrasimod, adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 Dec 2023 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 18 Nov 2023 (actual)
Results: Posted 24 Mar 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 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fixed Sequence	Experimental	Drug: Etrasimod Immediate Release (IR)Single oral dose of etrasimod 2mg tablet under fasted conditions with site staff led assessments and training on how to use wearable sensors followed by single oral dose 2mg tablet under fasted conditions with participant led assessments with wearable sensors.

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
Etrasimod Immediate Release (IR)An immediate release tablet	Drug	Fixed Sequence

Primary outcome

Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling
Time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period
AUC0-24 was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by clinical research unit (CRU) staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling
Time frame: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
AUC24hr-last was calculated as linear/log trapezoidal method. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling
Time frame: Pre-dose (0 hour), 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 AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast). Clast is the predicted plasma concentration at the last quantifiable time point and Kel is the terminal phase rate constant. PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.
Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling
Time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
PK sampling: a) Treatment F/Reference: Tasso PK micro sampling was done by CRU staff participants at the CRU up to 24 hours post-dose and by participants 48-168 hours post-dose remotely; b) Treatment G/Test: Tasso PK micro sampling was done by participants at the CRU up to 24 hours post-dose and 48-168 hours post-dose remotely.

11 secondary outcomes

AUC0-24 of Etrasimod: Tasso and Venous PK Sampling
Time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period
AUC24hr-last of Etrasimod: Tasso and Venous PK Sampling
Time frame: 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
AUCinf for Etrasimod: Tasso and Venous PK Sampling
Time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
Cmax for Etrasimod: Tasso and Venous PK Sampling
Time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose on Day 1 of each period
Change From Baseline in Heart Rate (HR) at 1, 2, 3, 4 ,5, 6, 8 and 24 Hours Post-dose on Day 1
Time frame: Baseline; 1, 2, 3 ,4, 5, 6, 8 and 24 hours post-dose on Day 1 of each period
Change From Baseline to Nadir in HR at Day 1
Time frame: Baseline; Anytime or latest time with minimum HR measurement taken post-dose on Day 1 of each period
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants With Clinically Significant Findings in Laboratory Abnormalities
Time frame: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants With Clinically Significant Findings in Vital Signs
Time frame: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants With Clinically Significant Findings in Physical Examination
Time frame: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days)
Number of Participants Categorized Per Pre-defined Electrocardiogram (ECG) Findings Criteria
Time frame: From Baseline (Day 1) maximum up to Day 17

Results and safety

Results posted to the registry on 24 Mar 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
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)	8	7
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)	0	0

Primary outcome: Area Under the Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling

Time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram*hour per milliliter (ng*hr/mL )

Measure	Period 1: Etrasimod 2mg (Treatment F, With Practice Session) n = 8	Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) n = 7
Value	666.4 (23)	745.5 (25)

Period 1: Etrasimod 2mg (Treatment F, With Practice Session) vs Period 2: Etrasimod 2mg (Treatment G, Without Practice Session): Ratio of Adjusted Geometric Means: 108.32 (90% CI 101.20 to 115.94)

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: Area Under the Serum Concentration-Time Profile From Time 24 Hours to the Time of the Last Quantifiable Concentration (AUC24hr-last) of Etrasimod: Tasso PK Sampling

Time frame: 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	Period 1: Etrasimod 2mg (Treatment F, With Practice Session) n = 8	Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) n = 6
Value	768.4 (37)	872.1 (16)

Period 1: Etrasimod 2mg (Treatment F, With Practice Session) vs Period 2: Etrasimod 2mg (Treatment G, Without Practice Session): Ratio of Adjusted Geometric Means: 120.41 (90% CI 108.02 to 134.22)

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. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Primary outcome: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of Etrasimod: Tasso PK Sampling

Time frame: Pre-dose (0 hour), 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	Period 1: Etrasimod 2mg (Treatment F, With Practice Session) n = 8	Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) n = 6
Value	1503 (32)	1652 (19)

Period 1: Etrasimod 2mg (Treatment F, With Practice Session) vs Period 2: Etrasimod 2mg (Treatment G, Without Practice Session): Ratio of Adjusted Geometric Means: 115.29 (90% CI 105.17 to 126.38)

Primary outcome: Maximum Observed Concentration (Cmax) of Etrasimod: Tasso PK Sampling

Time frame: Pre-dose (0 hour), 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 per milliliter (ng/mL)

Measure	Period 1: Etrasimod 2mg (Treatment F, With Practice Session) n = 8	Period 2: Etrasimod 2mg (Treatment G, Without Practice Session) n = 7
Value	40.65 (26)	44.63 (28)

Period 1: Etrasimod 2mg (Treatment F, With Practice Session) vs Period 2: Etrasimod 2mg (Treatment G, Without Practice Session): Ratio of Adjusted Geometric Means: 106.75 (90% CI 99.33 to 114.73)

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.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to 35 days after last dose of study treatment (maximum up to 45 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1: Etrasimod 2mg (Treatment F, With Practice Session)	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Period 2: Etrasimod 2mg (Treatment G, Without Practice Session)	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 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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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?

A Phase 1 study testing Etrasimod Immediate Release (IR) in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

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 24 Mar 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 24 Mar 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 Serum Concentration-Time Profile From Time Zero to 24 Hours (AUC0-24) of Etrasimod: Tasso PK Sampling (time frame: Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1 of each period). The study lists 4 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 NCT06140290.

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 24 Mar 2025.