Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140290
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2023-11-15
Brief Title:
A Sub Study to Evaluate the Study Medication Etrasimod Using Wearable Sensors in Healthy Participants
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C5041034 Sub-Study | OTHER | Alias Study Number | None |