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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05441215
Collaborator
(none)
8
Enrollment
1
Arm
13.2
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A PHASE I, MULTIPLE DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF NIRMATRELVIR/RITONAVIR IN HEALTHY LACTATING WOMEN
Anticipated Study Start Date :
Jul 5, 2022
Anticipated Primary Completion Date :
Aug 10, 2023
Anticipated Study Completion Date :
Aug 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nirmatrelvir/ritonavir

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

Drug: nirmatrelvir
nirmatrelvir/ritonavir
Other Names:
  • PF-07321332/ritonavir

    • Drug: ritonavir
    nirmatrelvir/ritonavir
    Other Names:
  • PF-07321332/ritonavir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Breastmilk Concentration (Cmax) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    2. Time to Reach Maximum Breastmilk Concentration (Tmax) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    3. Area under the breastmilk concentration time profile from time 0 to the time of the end of the dosing interval (tau) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    4. Terminal phase half life (t½) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    5. Average breastmilk concentration (Cav) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    6. Amount excreted in breast milk over the dosing interval (Aetau) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    7. Percent of dose excreted in breast milk during the dosing interval (Aetau %) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    8. Breast milk clearance (CLbm) of nirmatrelvir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    Secondary Outcome Measures

    1. Cmax of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    2. Tmax of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    3. Area under the breastmilk concentration time profile from time 0 to the time of the end of the dosing interval (Auc tau) of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    4. t½ of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    5. Cav of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    6. Aetau of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    7. Aetau % of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    8. CLbm of ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    9. Cmax of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    10. Cav of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    11. Pre-dose concentration (Ctrough) of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    12. Tmax of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    13. AUC tau of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    14. Minimum Observed Breastmilk Concentration (Cmin) of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    15. t½ of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    16. Apparent plasma clearance (CL/F) of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    17. Apparent volume of distribution (Vz/F) of nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    18. Daily (24 hour) amount of nirmatrelvir excreted in breast milk (Ae 24bm) [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    19. Breast milk to plasma ratio for AUC tau (MPAUC tau) for both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    20. Breast milk to plasma ratio for AUC tau (MPCmax during dosing interval tau) for both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    21. CLbm for both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    22. Milk to plasma ratio (M/P) of both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    23. Body weight normalized infant dose in μg/kg/day (BWNID) of both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    24. Body weight normalized maternal dose in μg/kg/day (BWNMD) of both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    25. Infant dose expressed as % of body weight normalized maternal dose (BWNIDPCM) of both nirmatrelvir and ritonavir [Day 2 (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours) and Day 3 (18, 24, 32, 40 hours) Day 4 (48 hours)]

    26. Participants reporting treatment emergent adverse events [Baseline to 28 days after last dose]

    27. Participants reporting abnormal clinical laboratory lab tests [Baseline to 28 days after last dose]

    28. Participants reporting abnormal vital signs [Baseline to 28 days after last dose]

    29. Participants reporting abnormal physical examination results [Baseline to 28 days after last dose]

    30. Participants reporting abnormal electrocardiograms [Baseline to 28 days after last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05441215
    Other Study ID Numbers:
    • C4671039
    • 2022-001020-15
    First Posted:
    Jul 1, 2022
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pfizer
    Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
    Lactation
    COVID-19
    Breastfeeding
    Protease Inhibitor
    Additional relevant MeSH terms:
    Ritonavir

    Study Results

    No Results Posted as of Jul 1, 2022