At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE I, MULTIPLE DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF NIRMATRELVIR/RITONAVIR IN HEALTHY LACTATING WOMEN
In Brief
A Phase 1 clinical trial evaluating nirmatrelvir and ritonavir for Healthy Participants. Completed, enrolled 8 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
nirmatrelvir/ritonavir
nirmatrelvir/ritonavir