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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06140290
• Other study ID #: C5041050
• Secondary ID: C5041034 Sub-Stu
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Etrasimod Immediate Release (IR)
An immediate release tablet

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (24 hour)	PK micro samples	Hour 0, 1, 2, 4, 6, 8, 12 and 24 hours postdose
Primary	Area under the curve (24 hour to last available)	PK micro samples	Hour 24, 48, 72, 96, 120, 144 and 168 hours postdose
Primary	Area under the curve (infinity) if data permits otherwise Area under the curve (last)	PK micro samples	Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
Primary	Cmax (maximum observed concentration)	PK micro samples	Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
Secondary	Area under the curve (24 hour)	micro samples and venous samples	Hour 0, 1, 2, 4, 6, 8, 12 and 24 hours postdose
Secondary	Area under the curve (24 hours to last available)	micro samples and venous samples	Hour 24, 48, 72, 96, 120, 144 and 168 hours postdose
Secondary	Area under the curve (infinity) if data permits otherwise area under the curve (last)	micro samples and venous samples	Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose
Secondary	Cmax (maximum observed concentration)	micro samples and venous samples	Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
Secondary	Number of participants with a clinically significant change from baseline heart rate		Hour 0-24
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline (Day 0) up to 35 days after last dose of study medication
Secondary	Number of Participants With clinically significant clinical laboratory abnormalities		Baseline (Day 0) up to 35 days after last dose of study medication
Secondary	Number of Participants With clinically significant vital signs change from baseline		Baseline (Day 0) up to 35 days after last dose of study medication
Secondary	Number of Participants With clinically significant physical exam changes from baseline		Baseline (Day 0) up to 35 days after last dose of study medication
Secondary	Number of Participants With clinically significant electrocardiogram changes from baseline		Baseline (Day 0) up to 35 days after last dose of study medication

External Links

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