Studie o léku (PF-07321332 nebo Nirmatrelvir/Ritonavir) u zdravých kojících žen
28. dubna 2026 aktualizováno: Pfizer
FÁZE I, VÍCENÁSOBNÁ, OTEVŘENÁ FARMAKOKINETICKÁ STUDIE NIRMATRELVIR/RITONAVIRU U ZDRAVÝCH KOJENÝCH ŽENY
Hlavním účelem této studie je změřit hladinu aktivní složky studovaného léku (nirmatrelvir), která se vylučuje do lidského mateřského mléka, když je podávána zdravým kojícím ženám. Studovaný lék se skládá ze dvou léků, nirmatrelviru a ritonaviru. Hledáme účastnice, které jsou:
- Aktivně kojit (kojit) alespoň 12 týdnů po porodu;
- Věk od 18 do 55 let a v současné době není těhotná;
- Mít index tělesné hmotnosti (BMI): 17,5 kg/m2; a celkovou tělesnou hmotnost >50 kg (110 lb).
Účastníci budou užívat studovaný lék ústy celkem 3krát během 2 dnů (2 ranní dávky a 1 večerní dávka) na studijní klinice. Od 2. do 4. dne budeme pravidelně sbírat mateřské mléko, abychom v něm změřili hladinu nirmatrelviru a ritonaviru. Přibližně 28–35 dní od poslední dávky bude proveden bezpečnostní následný hovor, aby se sledovaly případné reakce účastníků na studovaný lék.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
8
Fáze
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Bruxelles-capitale, Région de
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Brussels, Bruxelles-capitale, Région de, Belgie, B-1070
- Pfizer Clinical Research Unit - Brussels
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 55 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Popis
Kritéria pro zařazení:
- Zdravé kojící ženy, které aktivně kojí nebo odvádějí mateřské mléko, alespoň 12 týdnů po porodu a v současné době nejsou těhotné ve věku 18 až 55 let
- Index tělesné hmotnosti (BMI): 17,5 kg/m2; a celková tělesná hmotnost >50 kg (110 lb)
- Kojenci žen zařazených do studie musí být před zahájením studie schopni úspěšně krmit z láhve nebo jinou alternativní metodou krmení přiměřenou věku a musí být schopni tolerovat kojeneckou výživu, pokud matka nemá zásobu zásobního prsu mléko dostatečné k pokrytí doby trvání studie
- Účastníci musí být ochotni dočasně přerušit kojení svých dětí na celkem 4,5 dne (108 hodin)
- Účastníci musí být ochotni pravidelně odsávat prsa v průběhu studie a odsávat mléko podle plánu určeného k udržení laktace po celou dobu studie.
Kritéria vyloučení:
- Pozitivní výsledek testu (RT-PCR) na infekci SARS-CoV-2 v době screeningu nebo v den -1
- Důkaz nebo historie klinicky významných nálezů
- Anamnéza horečnatého onemocnění nebo mastitidy během 5 dnů před první dávkou studovaného léku
- Účastníci, kteří dostali vakcínu COVID-19 do 7 dnů před screeningem nebo přijetím, nebo kteří mají být vakcínou COVID-19 očkováni kdykoli během období studie
- Anamnéza infekce HIV, hepatitidy B nebo hepatitidy C; pozitivní testy na HIV, HBsAg nebo HCVAb. Očkování proti hepatitidě B je povoleno
- Abnormální vitální funkce, jako je krevní tlak, 12svodový elektrokardiogram
- Anamnéza zneužívání alkoholu a/nebo užívání nelegálních drog, užívání tabáku více než 5 cigaret/den nebo 2 žvýkání/den
- Darování krve do 60 dnů
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: nirmatrelvir/ritonavir
nirmatrelvir/ritonavir bude podáván ústy dvakrát denně jako tableta
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nirmatrelvir/ritonavir
Ostatní jména:
nirmatrelvir/ritonavir
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval
Časové okno: 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 and was directly observed from data.
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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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Time to Reach Cmax of Nirmatrelvir in Breast Milk
Časové okno: 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
Časové okno: 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
Časové okno: 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 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Clearance was defined as the apparent volume (Liter) of breast milk completely cleared the nirmatrelvir per hour.
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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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval
Časové okno: 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
Časové okno: 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.
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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
|
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Area Under the Concentration-Time Profile for Ritonavir in Breast Milk From Time Zero to End of Dosing Interval
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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The Percent of Ritonavir Excreted in Breast Milk Over The Dosing Interval Tau
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Area Under the Concentration-Time Profile for Ritonavir in Plasma From Time Zero to End of Dosing Interval
Časové okno: 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
Časové okno: 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
|
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Half-Life of Ritonavir in Plasma
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
|
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Time to Reach Cmax of Nirmatrelvir in Plasma
Časové okno: 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.
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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 Ritonavir in Plasma
Časové okno: 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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Cmax was defined as maximum observed concentration of ritonavir in plasma.
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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 Clearance of Nirmatrelvir From Plasma
Časové okno: 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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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
|
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Apparent Clearance of Ritonavir From Plasma
Časové okno: 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.
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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 Nirmatrelvir Distribution
Časové okno: 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
Časové okno: 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.
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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 Average Steady State Concentration of Nirmatrelvir in Plasma
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Milk to Plasma Ratio of Nirmatrelvir for AUCtau During Dosing Interval
Časové okno: 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
|
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Milk to Plasma Ratio of Ritonavir for AUCtau During Dosing Interval
Časové okno: 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
|
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Milk to Plasma Ratio of Nirmatrelvir for Cmax During Dosing Interval
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
12. prosince 2022
Primární dokončení (Aktuální)
15. prosince 2023
Dokončení studie (Aktuální)
15. prosince 2023
Termíny zápisu do studia
První předloženo
28. června 2022
První předloženo, které splnilo kritéria kontroly kvality
28. června 2022
První zveřejněno (Aktuální)
1. července 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. dubna 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Infekce dýchacích cest
- Infekce
- RNA virové infekce
- Virová onemocnění
- Nemoci dýchacích cest
- Plicní onemocnění
- Pneumonie, virová
- Zápal plic
- Koronavirové infekce
- Infekce Coronaviridae
- Infekce Nidovirales
- Chování
- Chování při krmení
- COVID-19
- Kojení
- Sloučeniny síry
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Thiazoles
- Azoly
- Ritonavir
- Kombinace drog Nirmatrelvir a Ritonavir
- Nirmatrelvir
Další identifikační čísla studie
- C4671039
- 2022-001020-15 (Číslo EudraCT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Společnost Pfizer poskytne přístup k jednotlivým neidentifikovaným údajům účastníků a souvisejícím studijním dokumentům (např.
protokol, plán statistické analýzy (SAP), zprávu o klinické studii (CSR)) na žádost kvalifikovaných výzkumných pracovníků a za určitých kritérií, podmínek a výjimek.
Další podrobnosti o kritériích sdílení dat společnosti Pfizer a procesu žádosti o přístup naleznete na adrese: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .