NCT05441215

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

A PHASE I, MULTIPLE DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF NIRMATRELVIR/RITONAVIR IN HEALTHY LACTATING WOMEN

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	nirmatrelvir	nirmatrelvir/ritonavir
DRUG	ritonavir	nirmatrelvir/ritonavir

Timeline

• Start date: 2022-12-12
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2022-07-01
• Last updated: 2024-04-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study