Clinical trial NCT06140290: A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: etrasimod
adults
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.


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