Status:
COMPLETED
A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women. ...
Eligibility Criteria
Inclusion
- Healthy lactating females who are actively breast-feeding or expressing breast milk, at least 12 weeks post-partum and not currently pregnant between 18 and 55 years old
- Body Mass Index (BMI): 17.5 kg/m2; and a total body weight \>50 kg (110 lb)
- Infants of women enrolled in the study must be able to feed successfully from a bottle or other age-appropriate alternative feeding method prior to the start of the study and must be able to tolerate infant formula if the mother does not have a supply of stored breast milk sufficient to cover the duration of the study
- Participants must be willing to temporarily discontinue breast feeding their infants for a total of 4.5 days (108 hours)
- Participants must be willing to regularly pump breasts throughout the study and express milk according to a schedule designed to maintain lactation throughout the study period
Exclusion
- Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of screening or Day -1
- Evidence or history of clinically significant findings
- History of febrile illness or mastitis within 5 days prior to the first dose of study medication
- Participants who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
- Abnormal vital signs such as blood pressure, 12-lead electrocardiogram
- History of alcohol abuse and/or illicit drug use, tobacco use in excess of 5 cigarettes/day or 2 chews/day
- Blood donation within 60 days
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05441215
Start Date
December 12 2022
End Date
December 15 2023
Last Update
April 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium, B-1070