A Study to Learn About the Medicine Called Nirmatrelvir/Ritonavir in Healthy Lactating Women

• Status: Not yet recruiting
• Trial end date: 2023-08-10
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this trial is to measure the amount of study drug (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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