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En studie for å lære om medisinen (PF-07321332 eller Nirmatrelvir/Ritonavir) hos friske ammende kvinner

28. april 2026 oppdatert av: Pfizer

EN FASE I, FLERE DOSER, ÅPEN LABEL FARMAKOKINETISK STUDIE AV NIRMATRELVIR/RITONAVIR HOS SUNNE AMEDE KVINNER

Hovedformålet med denne studien er å måle nivået av virkestoffet i studiemedisinen (nirmatrelvir) som skilles ut i morsmelk når det gis til friske ammende kvinner. Studiemedisinen består av to medisiner, nirmatrelvir og ritonavir. Vi søker kvinnelige deltakere som er:

  • Aktivt amming (ammende) minst 12 uker etter fødselen;
  • Alder mellom 18 og 55 år og ikke gravid;
  • Har en kroppsmasseindeks (BMI): 17,5 kg/m2; og en total kroppsvekt >50 kg (110 lb).

Deltakerne vil ta studiemedisinen gjennom munnen i totalt 3 ganger over 2 dager (2 morgendoser og 1 kveldsdose) ved studieklinikken. Vi vil med jevne mellomrom samle inn morsmelk fra dag 2 til 4 for å måle nivået av nirmatrelvir og ritonavir i den. En sikkerhetsoppfølgingssamtale vil bli utført rundt 28-35 dager fra siste dose for å overvåke eventuelle reaksjoner deltakerne måtte ha på studiemedisinen.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

8

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
    • Bruxelles-capitale, Région de
      • Brussels, Bruxelles-capitale, Région de, Belgia, B-1070
        • Pfizer Clinical Research Unit - Brussels

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Beskrivelse

Inklusjonskriterier:

  • Friske ammende kvinner som aktivt ammer eller pumper ut morsmelk, minst 12 uker etter fødselen og som for øyeblikket ikke er gravide mellom 18 og 55 år
  • Kroppsmasseindeks (BMI): 17,5 kg/m2; og en total kroppsvekt >50 kg (110 lb)
  • Spedbarn til kvinner som er registrert i studien må kunne fôres med suksess fra flaske eller annen alderstilpasset alternativ fôringsmetode før studiestart og må kunne tolerere morsmelkerstatning dersom moren ikke har tilførsel av lagret bryst melk tilstrekkelig til å dekke varigheten av studien
  • Deltakerne må være villige til midlertidig å slutte å amme spedbarnene sine i totalt 4,5 dager (108 timer)
  • Deltakerne må være villige til regelmessig å pumpe bryster gjennom hele studien og pumpe ut melk i henhold til en tidsplan designet for å opprettholde amming gjennom hele studieperioden

Ekskluderingskriterier:

  • Positivt testresultat (RT-PCR) for SARS-CoV-2-infeksjon på tidspunktet for screening eller dag -1
  • Bevis eller historie med klinisk signifikante funn
  • Anamnese med febersykdom eller mastitt innen 5 dager før første dose med studiemedisin
  • Deltakere som har mottatt en covid-19-vaksine innen 7 dager før screening eller innleggelse, eller som skal vaksineres med en covid-19-vaksine når som helst i løpet av studietiden
  • Anamnese med HIV-infeksjon, hepatitt B eller hepatitt C; positiv testing for HIV, HBsAg eller HCVAb. Hepatitt B-vaksinasjon er tillatt
  • Unormale vitale tegn som blodtrykk, 12-avlednings elektrokardiogram
  • Historie med alkoholmisbruk og/eller ulovlig bruk av narkotika, tobakksbruk i overkant av 5 sigaretter/dag eller 2 tygger/dag
  • Bloddonasjon innen 60 dager

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: nirmatrelvir/ritonavir
nirmatrelvir/ritonavir gis gjennom munnen to ganger daglig som en tablett
Legemiddel: nirmatrelvir
nirmatrelvir/ritonavir
Andre navn:
  • PF-07321332/ritonavir
Legemiddel: ritonavir
nirmatrelvir/ritonavir
Andre navn:
  • PF-07321332/ritonavir

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The maximum observed concentration and was directly observed from data.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Time to Reach Cmax of Nirmatrelvir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Cmax was defined as maximum observed concentration of nirmatrelvir in breast milk.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area Under the Concentration-Time Profile From Time Zero to End of Dosing Interval for Nirmatrelvir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Terminal Half-Life of Nirmatrelvir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The time measured for the breast milk nirmatrelvir concentration to decrease by one half.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Average Steady State Concentration of Nirmatrelvir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Amount of Nirmatrelvir Excreted in Breast Milk Over the Dosing Interval Tau
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The amount of nirmatrelvir excreted into breast milk over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Percent of Amount of Nirmatrelvir Excreted in Breast Milk Over The Dosing Interval Tau
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The percent of nirmatelvir excreted in breast milk to amount of breast milk over the dosing interval .
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Breast Milk Clearance of Nirmatrelvir
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Clearance was defined as the apparent volume (Liter) of breast milk completely cleared the nirmatrelvir per hour.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The maximum observed concentration and was directly observed from data.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Time to Reach Cmax of Ritonavir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Cmax was defined as maximum observed concentration of ritonavir in breast milk.
At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area Under the Concentration-Time Profile for Ritonavir in Breast Milk From Time Zero to End of Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Area under the concentration curve for ritonavir in breast milk from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Half-Life of Ritonavir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The time measured for the breast milk ritonavir concentration to decrease by one half.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Average Steady State Concentration of Ritonavir in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Amount of Ritonavir Excreted in Breast Milk Over the Dosing Interval Tau
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The amount of ritonavir excreted into breast milk over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Percent of Ritonavir Excreted in Breast Milk Over The Dosing Interval Tau
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The percent of ritonavir excreted in breast milk to amount of breast milk over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Breast Milk Clearance of Ritonavir
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Clearance was defined as the apparent volume (L) of breast milk completely cleared the ritonavir per hour.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The Maximum Observed Concentration of Nirmatrelvir in Plasma Observed Over the Dosing Interval
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The maximum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Maximum Observed Concentration of Ritonavir in Plasma Observed Over the Dosing Interval
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The maximum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area Under the Concentration-Time Profile for Nirmatrelvir in Plasma From Time Zero to End of Dosing Interval
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area Under the Concentration-Time Profile for Ritonavir in Plasma From Time Zero to End of Dosing Interval
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Area under the concentration curve for ritonavir in plasma from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Half-Life of Nirmatrelvir in Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The time measured for the plasma nirmatrelvir concentration to decrease by one half.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Half-Life of Ritonavir in Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The time measured for the plasma ritonavir concentration to decrease by one half.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Minimum Plasma Concentration of Nirmatrelvir Observed Over the Dosing Interval
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The minimum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Minimum Plasma Concentration of Ritonavir Observed Over the Dosing Interval
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The minimum observed concentration and was directly observed from data.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Time to Reach Cmax of Nirmatrelvir in Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Cmax was defined as maximum observed concentration of nirmatrelvir in plasma.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Time to Reach Cmax of Ritonavir in Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Cmax was defined as maximum observed concentration of ritonavir in plasma.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Clearance of Nirmatrelvir From Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Clearance was defined as the apparent volume (L) of plasma completely cleared the nirmatrelvir per hour.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Clearance of Ritonavir From Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Clearance was defined as the apparent volume (L) of plasma completely cleared the ritonavir per hour.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Volume of Nirmatrelvir Distribution
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Apparent Volume of Ritonavir Distribution
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Average Steady State Concentration of Nirmatrelvir in Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The Average Steady State Concentration of Ritonavir in Plasma
Tidsramme: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.
At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
Daily (24 Hour) Amount of Nirmatrelvir Excreted in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Amount of nirmatrelvir excreted in breast milk in 24 hours.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Daily (24 Hour) Amount of Ritonavir Excreted in Breast Milk
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Amount of ritonavir excreted in breast milk in 24 hours.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Nirmatrelvir for AUCtau During Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of area under the concentration-time profile for nirmatrelvir in milk to those in plasma from time zero to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Ritonavir for AUCtau During Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of area under the concentration-time profile for ritonavir in milk to those in plasma from time zero to end of dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Nirmatrelvir for Cmax During Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of the maximum concentration of nirmatrelvir in breast milk to those in plasma observed over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Milk to Plasma Ratio of Ritonavir for Cmax During Dosing Interval
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
The ratio of the maximum concentration of ritonavir in breast milk to those in plasma observed over the dosing interval.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Body Weight Normalized Infant Dose (BWNID) of Nirmatrelvir in mg/kg/Day
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNID of Ritonavir in mg/kg/Day
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Body Weight Normalized Maternal Dose (BWNMD) of Nirmatrelvir in mg/kg/Day
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNMD of Ritonavir in mg/kg/Day
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Infant Dose Expressed As % of Body Weight Normalized Maternal Dose (BWNIDPCM) for Nirmatrelvir
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNIDPCM = 100 * BWNID / BWNMD.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNIDPCM for Ritonavir
Tidsramme: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
BWNIDPCM = 100 * BWNID / BWNMD.
At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2
Number of Participants With Treatment Emergent Adverse Events
Tidsramme: From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.
From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days)
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Tidsramme: At Screening (Day -28 to Day -2), Day -1, and Day 4
The laboratory abnormality parameters included urinalysis: urine bilirubin (>=1), urine hemoglobin (>=1) and leukocyte esterase (>=1).
At Screening (Day -28 to Day -2), Day -1, and Day 4
Number of Participants With Vital Signs Abnormalities
Tidsramme: At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2
Single supine blood pressure (BP), and pulse rate (PR) were performed following approximately a 5-minute rest in a supine position. BP, and PR assessments will be performed after collection of electrocardiogram (ECGs) and prior to collection of blood draws if scheduled at the same time. Vital signs abnormality included supine systolic BP <90mmHg.
At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2
Number of Participants With ECG Abnormalities
Tidsramme: At Screening (from Day -28 to Day -2)
Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.
At Screening (from Day -28 to Day -2)
Number of Participants With Physical Examination Abnormalities
Tidsramme: At Screening (from Day -28 to Day -2) or Day -1
Physical examination included height, weight and body mass index (BMI, BMI = weight [kg] / height [m^2]) obtained for eligibility criteria. Physical examination abnormalities: BMI <17.5 kg/m^2; and a total body weight <=50 kg (110 lb).
At Screening (from Day -28 to Day -2) or Day -1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. desember 2022

Primær fullføring (Faktiske)

15. desember 2023

Studiet fullført (Faktiske)

15. desember 2023

Datoer for studieregistrering

Først innsendt

28. juni 2022

Først innsendt som oppfylte QC-kriteriene

28. juni 2022

Først lagt ut (Faktiske)

1. juli 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • C4671039
  • 2022-001020-15 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere