Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520930-44-00 | Registry Identifier | CTIS (EU) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to figure out how much etrasimod, a medication, ends up in breast milk after taking it for several days. To do this, the researchers will work with at least 8 healthy women who are breastfeeding. These women will take a 2 mg dose of etrasimod every day for 7 days while staying at the testing site. During the study, they won't be allowed to breastfeed their babies to keep the babies safe. Instead, they need to have another plan for feeding their babies during this time. The study will look at how the medication is absorbed and how it moves through the body, checking things like the highest level in the blood and how long it takes to reach that level. The researchers will also see how much of the drug is in the breast milk compared to the blood and whether it's safe for the women to take. After the last dose, the women will stay at the site for at least another 24 hours before going home, and follow-up safety calls will be made about 14 and 28 to 35 days later. The whole process from start to finish will take about 10 weeks
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy breast feeding volunteers | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etrasimod | Drug | Oral 2 milligrams tablet, once a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the etrasimod concentration-time curve in breast milk | Baseline (Day -1), Day 1, Day 7 and Day 8. | |
| Maximum observed concentration of etrasimod in breast milk | Baseline (Day -1), Day 1, Day 7 and Day 8. | |
| Amount of etrasimod excreted in breast milk | Baseline (Day -1), Day 1, Day 7 and Day 8. | |
| Percent of etrasimod dose excreted in breast milk | Baseline (Day -1), Day 1, Day 7 and Day 8. | |
| Breast milk clearance of etrasimod | Baseline (Day -1), Day 1, Day 7 and Day 8. | Baseline through Day 8 |
| Time to maximum observed concentration of etrasimod | Baseline (Day -1), Day 1, Day 7 and Day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the etrasimod concentration-time curve in plasma | Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24 | |
| Maximum observed concentration of etrasimod in plasma | Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24 |
Not provided
Inclusion
Exclusion
Female participants
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Recruiting | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000656249 | etrasimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Time to maximum observed concentration of etrasimod in plasma | Day 1 hour 0, Day 7 hour 0, 1, 2, 4, 6, 8 and 12, Day 8 hour 24 |
| Breast milk to plasma ratio for area under the concentration-time curve | Baseline (Day -1), Day 1, Day 7 and Day 8. |
| percentage of treatment emergent adverse events in participants | Baseline through Day 35 |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Baseline through Day 8 |
| Number of Participants With Clinically Significant Change From Baseline in vital signs (blood pressure and heart rate) | Baseline through Day 8 |
| Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters | Baseline through Day 8 |
| Body weight normalized infant dose in μg/kg/day | Baseline through Day 8 |
| Body weight normalized maternal dose in μg/kg/day | Baseline through Day 8 |
| Infant dose expressed as % of body weight normalized maternal dose | Baseline through Day 8 |