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NCT06453356 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT06453356 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 12 participants.
The verdict
NCT06453356, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding. The study is seeking for about 12 healthy breast-feeding females who are: * 18 to 55 years of age. * actively breast-feeding or producing breast milk. * at least 2 weeks post-partum and not pregnant at present. Participants will not be allowed to breast-feed their infant from the evening of the day before to the first dose till 48 hours (2 days) after the dose. Eligible participants will check into the clinical research unit (CRU) on Day -1. Participants will receive the zavegepant dose sprayed into the nose at the CRU on Day 1. The participants will stay at the CRU until the morning of Day 2. There will be collections of breast milk and plasma over 24 hours. Participants will be sent from the CRU on Day 2 and may begin to breastfeed their infant 48 hours (2 days) after the dose. A safety follow-up call will be done at about 28 to 35 days from the day the first dose of study medicine was given.
Interventions
- DRUG Zavegepant 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2024-09-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06453356
The ClinicalTrials.gov registry entry for NCT06453356 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zavegepant 10mg is the first listed.
NCT06453356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06453356 about?
NCT06453356 is a clinical study titled "A Study to Learn How the Study Medicine Called Zavegepant is Taken Up Into Blood and Breast Milk of Healthy Breast-Feeding Women". The purpose of the study is to look at the amount of zavegepant that is present in breast milk after single dose of zavegepant is sprayed through the nose in healthy breast-feeding women. This would allow to see if there are any possible risk to infants from medicines during breast-feeding. The stu...
What is the current status of trial NCT06453356?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-06-10. Estimated completion is 2024-09-26.
What interventions are being tested in trial NCT06453356?
The interventions under investigation include: Zavegepant 10mg (DRUG).
Who is sponsoring clinical trial NCT06453356?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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