A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-12-15

Brief Summary

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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. The study medicine consists of two medicines, nirmatrelvir and ritonavir. We are seeking female participants who are:

* Actively breast-feeding (lactating) at least 12 weeks postpartum;
* Age between 18 to 55 years and not currently pregnant;
* Have a Body Mass Index (BMI): 17.5 kg/m2; and a total body weight \>50 kg (110 lb).

Participants will take the study medicine by mouth for a total of 3 times over 2 days (2 morning doses and 1 evening dose) at the study clinic. We will periodically collect breast milk from day 2 to 4 to measure the level of nirmatrelvir and ritonavir in it. A safety follow up call will be conducted around 28-35 days from the last dose to monitor any reactions participants may have to the study medicine.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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nirmatrelvir/ritonavir

nirmatrelvir/ritonavir will be given by mouth two times a day as a tablet

Group Type EXPERIMENTAL

nirmatrelvir

Intervention Type DRUG

nirmatrelvir/ritonavir

ritonavir

Intervention Type DRUG

nirmatrelvir/ritonavir

Interventions

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nirmatrelvir

nirmatrelvir/ritonavir

Intervention Type DRUG

ritonavir

nirmatrelvir/ritonavir

Intervention Type DRUG

Other Intervention Names

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PF-07321332/ritonavir PF-07321332/ritonavir

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes