Terveiden imettävien naisten lääketieteellinen tutkimus (PF-07321332 tai Nirmatrelvir/Ritonavir)
tiistai 28. huhtikuuta 2026 päivittänyt: Pfizer
VAIHE I, USEITA ANNOKSIA, AVAINLAITE FARMAKOKINEETTINEN TUTKIMUS NIRMATRELVIRISTA/RITONAVIRISTA TERVEILLÄ IMETTÄVIÄ NAISIA
Tämän tutkimuksen päätarkoituksena on mitata tutkittavan lääkkeen vaikuttavan aineen (nirmatrelviirin) tasoa, joka erittyy ihmisen rintamaitoon, kun sitä annetaan terveille imettäville naisille. Tutkimuslääke koostuu kahdesta lääkkeestä, nirmatrelviirista ja ritonaviirista. Haemme naispuolisia osallistujia:
- Aktiivinen imetys (imetys) vähintään 12 viikkoa synnytyksen jälkeen;
- Ikä 18–55 vuotta, ei tällä hetkellä raskaana;
- Kehon massaindeksi (BMI): 17,5 kg/m2; ja kokonaispaino yli 50 kg (110 lb).
Osallistujat ottavat tutkimuslääkettä suun kautta yhteensä 3 kertaa 2 päivän aikana (2 aamuannosta ja 1 iltaannos) tutkimusklinikalla. Keräämme säännöllisesti rintamaitoa päivästä 2-4 mitataksemme sen nirmatrelviirin ja ritonaviirin pitoisuutta. Turvallisuusseuranta suoritetaan noin 28–35 päivän kuluttua viimeisestä annoksesta, jotta voidaan seurata mahdollisia osallistujien reaktioita tutkimuslääkkeeseen.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
8
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Bruxelles-capitale, Région de
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Brussels, Bruxelles-capitale, Région de, Belgia, B-1070
- Pfizer Clinical Research Unit - Brussels
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 55 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
Sisällyttämiskriteerit:
- Terveet imettävät naiset, jotka imettävät aktiivisesti tai erittävät rintamaitoa, vähintään 12 viikkoa synnytyksen jälkeen ja jotka eivät ole tällä hetkellä raskaana 18-55-vuotiaat
- painoindeksi (BMI): 17,5 kg/m2; ja kokonaispaino yli 50 kg (110 lb)
- Tutkimukseen osallistuneiden naisten imeväisten on kyettävä ruokkimaan onnistuneesti pullosta tai muusta ikään sopivasta vaihtoehtoisesta ruokintamenetelmästä ennen tutkimuksen aloittamista, ja heidän tulee sietää äidinmaidonkorviketta, jos äidillä ei ole varastoitua rintaa. maitoa, joka riittää kattamaan tutkimuksen ajan
- Osallistujien on oltava valmiita keskeyttämään väliaikaisesti imetyksensä yhteensä 4,5 päiväksi (108 tunniksi)
- Osallistujien on oltava valmiita pumppaamaan säännöllisesti rintoja koko tutkimuksen ajan ja lypsämään maitoa aikataulun mukaisesti, joka on suunniteltu ylläpitämään imetys koko tutkimusjakson ajan
Poissulkemiskriteerit:
- Positiivinen testitulos (RT-PCR) SARS-CoV-2-infektiolle seulonnan aikana tai päivänä -1
- Todisteet tai historia kliinisesti merkittävistä löydöksistä
- Kuumesairaus tai utaretulehdus 5 päivän aikana ennen ensimmäistä tutkimuslääkitysannosta
- Osallistujat, jotka ovat saaneet COVID-19-rokotteen 7 päivän sisällä ennen seulontaa tai maahanpääsyä tai jotka rokotetaan COVID-19-rokotteella milloin tahansa tutkimusajan aikana
- HIV-infektio, hepatiitti B tai hepatiitti C; positiivinen HIV-, HBsAg- tai HCVAb-testi. Hepatiitti B -rokote on sallittu
- Epänormaalit elintoiminnot, kuten verenpaine, 12-kytkentäinen EKG
- Alkoholin väärinkäyttö ja/tai laittomien huumeiden käyttö, tupakan käyttö yli 5 savuketta/päivä tai 2 pureskelua/vrk
- Verenluovutus 60 päivän sisällä
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: nirmatrelviiri/ritonaviiri
nirmatrelviiri/ritonaviiri annetaan suun kautta kaksi kertaa vuorokaudessa tabletteina
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nirmatrelviiri/ritonaviiri
Muut nimet:
nirmatrelviiri/ritonaviiri
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval
Aikaikkuna: 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
|
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Time to Reach Cmax of Nirmatrelvir in Breast Milk
Aikaikkuna: 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
|
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Area Under the Concentration-Time Profile From Time Zero to End of Dosing Interval for Nirmatrelvir in Breast Milk
Aikaikkuna: 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
|
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Terminal Half-Life of Nirmatrelvir in Breast Milk
Aikaikkuna: 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
|
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The Average Steady State Concentration of Nirmatrelvir in Breast Milk
Aikaikkuna: 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
|
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The Amount of Nirmatrelvir Excreted in Breast Milk Over the Dosing Interval Tau
Aikaikkuna: 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
|
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The Percent of Amount of Nirmatrelvir Excreted in Breast Milk Over The Dosing Interval Tau
Aikaikkuna: 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
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The percent of nirmatelvir excreted in breast milk to amount of breast milk over the dosing interval .
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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
|
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Breast Milk Clearance of Nirmatrelvir
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval
Aikaikkuna: 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
|
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Time to Reach Cmax of Ritonavir in Breast Milk
Aikaikkuna: 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
Aikaikkuna: 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
|
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Half-Life of Ritonavir in Breast Milk
Aikaikkuna: 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
|
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The Average Steady State Concentration of Ritonavir in Breast Milk
Aikaikkuna: 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
|
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The Amount of Ritonavir Excreted in Breast Milk Over the Dosing Interval Tau
Aikaikkuna: 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
Aikaikkuna: 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
|
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Breast Milk Clearance of Ritonavir
Aikaikkuna: 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
|
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The Maximum Observed Concentration of Nirmatrelvir in Plasma Observed Over the Dosing Interval
Aikaikkuna: 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
|
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The Maximum Observed Concentration of Ritonavir in Plasma Observed Over the Dosing Interval
Aikaikkuna: 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
|
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Area Under the Concentration-Time Profile for Nirmatrelvir in Plasma From Time Zero to End of Dosing Interval
Aikaikkuna: 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
Aikaikkuna: 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
|
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Half-Life of Nirmatrelvir in Plasma
Aikaikkuna: 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
Aikaikkuna: 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
|
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The Minimum Plasma Concentration of Nirmatrelvir Observed Over the Dosing Interval
Aikaikkuna: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
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The minimum observed concentration and was directly observed from data.
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At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
|
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The Minimum Plasma Concentration of Ritonavir Observed Over the Dosing Interval
Aikaikkuna: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
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The minimum observed concentration and was directly observed from data.
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At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
|
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Time to Reach Cmax of Nirmatrelvir in Plasma
Aikaikkuna: 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
|
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Time to Reach Cmax of Ritonavir in Plasma
Aikaikkuna: 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
|
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Apparent Clearance of Nirmatrelvir From Plasma
Aikaikkuna: 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.
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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
Aikaikkuna: 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
|
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Apparent Volume of Nirmatrelvir Distribution
Aikaikkuna: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
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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.
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At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2
|
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Apparent Volume of Ritonavir Distribution
Aikaikkuna: 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
|
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The Average Steady State Concentration of Nirmatrelvir in Plasma
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
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Tutkijat
- Opintojohtaja: Pfizer CT.gov Call Center, Pfizer
Julkaisuja ja hyödyllisiä linkkejä
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Hyödyllisiä linkkejä
Opintojen ennätyspäivät
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Opintoihin ilmoittautumispäivät
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Hengitysteiden infektiot
- Infektiot
- RNA-virusinfektiot
- Virussairaudet
- Hengityselinten sairaudet
- Keuhkosairaudet
- Keuhkokuume, virus
- Keuhkokuume
- Koronavirusinfektiot
- Coronaviridae-infektiot
- Nidovirales-infektiot
- Käyttäytyminen
- Ruokintakäyttäytyminen
- COVID-19
- Imetys
- Rikkiyhdisteet
- Orgaaniset kemikaalit
- Heterosykliset yhdisteet, 1-rengas
- Heterosykliset yhdisteet
- Tiatsolit
- Atsolit
- Ritonaviiri
- NirmaTrelviir- ja ritonaviir -lääkeyhdistelmä
- niratrelviir
Muut tutkimustunnusnumerot
- C4671039
- 2022-001020-15 (EudraCT-numero)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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protokolla, tilastollinen analyysisuunnitelma (SAP), kliininen tutkimusraportti (CSR)) pätevien tutkijoiden pyynnöstä ja tietyin kriteerein, ehdoin ja poikkeuksin.
Lisätietoja Pfizerin tietojen jakamiskriteereistä ja käyttöoikeuden pyytämisprosessista on osoitteessa https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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