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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956002
• Other study ID #: C5041034
• Secondary ID: 2023-504411-32-0
• Status: Completed
• Phase: Phase 1
• Start date: September 4, 2023
• Est. completion date: January 4, 2024

Study information

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

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 4, 2024
• Est. primary completion date: January 4, 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:
• Estraimod Immediate Release (IR)
an immediate release tablet
• Etrasimod Mini Tab in water
very small tablet mixed in water
• Etrasimod Mini Tab in chocolate pudding
very small tablet mixed in chocolate pudding
• Etrasimod Mini Tab in yogurt
Very small tablet mixed in yogurt
• Etrasimod Mini Tab in applesauce
Very small tablet mixed in applesauce

Locations

Country	Name	City	State
Belgium	Brussels Clinical Research Unit	Brussel
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 (last)		Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
Primary	Area under the curve (infinity)		Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
Primary	Cmax (maximum observed concentration)		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 65 days after last dose of study medication
Secondary	Number of Participants With clinically significant clinical laboratory abnormalities		Baseline (Day 0) up to 65 days after last dose of study medication
Secondary	Number of Participants With clinically significant vital signs change from baseline		Baseline (Day 0) up to 65 days after last dose of study medication
Secondary	Number of Participants With clinically significant physical exam changes from baseline		Baseline (Day 0) up to 65 days after last dose of study medication
Secondary	Number of Participants With clinically significant electrocardiogram changes from baseline		Baseline (Day 0) up to 65 days after last dose of study medication
Secondary	Mean degree of likeness of mouth feel of mini tablets	Mouth feel assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire.	minutes after dosing: 1, 5, 10, 20
Secondary	Mean degree of likeness of bitterness of mini tablets	Bitterness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire.	minutes after dosing: 1, 5, 10, 20
Secondary	Mean degree of likeness of tongue/mouth burn of mini tablets	Tongue/mouth burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire.	minutes after dosing: 1, 5, 10, 20
Secondary	Mean degree of likeness of throat burn of mini tablets	Throat burn assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire.	minutes after dosing: 1, 5, 10, 20
Secondary	Mean overall degree of likeness of mini tablets	Overall likeness assesses the degree that a participant experienced this sensory attribute after tasting a drug formulation. It is scored based on a measurement of taste questionnaire.	minutes after dosing: 1, 5, 10, 20

External Links

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