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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06140290
Collaborator
(none)
8
Enrollment
1
Arm
1.7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Etrasimod Immediate Release (IR)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Nov 20, 2023
Anticipated Primary Completion Date :
Jan 11, 2024
Anticipated Study Completion Date :
Jan 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fixed Sequence

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.

Drug: Etrasimod Immediate Release (IR)
an immediate release tablet

Outcome Measures

Primary Outcome Measures

  1. Area under the curve (24 hour) [Hour 0, 1, 2, 4, 6, 8, 12 and 24 hours postdose]

    PK micro samples

  2. Area under the curve (24 hour to last available) [Hour 24, 48, 72, 96, 120, 144 and 168 hours postdose]

    PK micro samples

  3. Area under the curve (infinity) if data permits otherwise Area under the curve (last) [Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose]

    PK micro samples

  4. Cmax (maximum observed concentration) [Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose]

    PK micro samples

Secondary Outcome Measures

  1. Area under the curve (24 hour) [Hour 0, 1, 2, 4, 6, 8, 12 and 24 hours postdose]

    micro samples and venous samples

  2. Area under the curve (24 hours to last available) [Hour 24, 48, 72, 96, 120, 144 and 168 hours postdose]

    micro samples and venous samples

  3. Area under the curve (infinity) if data permits otherwise area under the curve (last) [Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose]

    micro samples and venous samples

  4. Cmax (maximum observed concentration) [Hour 0, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose]

    micro samples and venous samples

  5. Number of participants with a clinically significant change from baseline heart rate [Hour 0-24]

  6. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline (Day 0) up to 35 days after last dose of study medication]

  7. Number of Participants With clinically significant clinical laboratory abnormalities [Baseline (Day 0) up to 35 days after last dose of study medication]

  8. Number of Participants With clinically significant vital signs change from baseline [Baseline (Day 0) up to 35 days after last dose of study medication]

  9. Number of Participants With clinically significant physical exam changes from baseline [Baseline (Day 0) up to 35 days after last dose of study medication]

  10. Number of Participants With clinically significant electrocardiogram changes from baseline [Baseline (Day 0) up to 35 days after last dose of study medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT06140290
Other Study ID Numbers:
  • C5041050
  • C5041034 Sub-Study
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
etrasimod
adults

Study Results

No Results Posted as of Nov 18, 2023