健康な授乳中の女性における薬（PF-07321332またはNirmatrelvir / Ritonavir）について学ぶための研究
2026年4月28日 更新者：Pfizer
健康な授乳中の女性における NIRMATRELVIR/RITONAVIR の第 I 相、複数回投与、非盲検薬物動態研究
この研究の主な目的は、健康な母乳育児中の女性に与えられたときに、ヒトの母乳に分泌される研究薬（ニルマトレルビル）の有効成分のレベルを測定することです。 研究薬は、ニルマトレルビルとリトナビルの2つの薬で構成されています。 以下のような女性の参加者を募集しています。
- 産後少なくとも 12 週間は積極的に授乳している (授乳中);
- 年齢が 18 歳から 55 歳で、現在妊娠していない。
- 体格指数 (BMI) を持っている: 17.5 kg/m2;および総体重が 50 kg (110 ポンド) を超える。
参加者は、治験クリニックで 2 日間にわたって計 3 回（朝 2 回、夜 1 回）、治験薬を口から服用します。 2日目から4日目まで定期的に母乳を採取し、その中のニルマトレルビルとリトナビルのレベルを測定します. 参加者が治験薬に対して持つ可能性のある反応を監視するために、最後の投与から約28〜35日後に安全性のフォローアップコールが実施されます。
調査の概要
研究の種類
介入
入学 (実際)
8
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Bruxelles-capitale, Région de
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Brussels、Bruxelles-capitale, Région de、ベルギー、B-1070
- Pfizer Clinical Research Unit - Brussels
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
はい
説明
包含基準:
- 活発に授乳中または母乳をさく乳している健康な授乳中の女性で、分娩後少なくとも 12 週間で、現在妊娠していない 18 歳から 55 歳までの女性
- 体格指数 (BMI): 17.5 kg/m2;および総体重が 50 kg (110 ポンド) を超える
- 研究に登録された女性の乳児は、哺乳瓶またはその他の年齢に適した代替摂食方法から研究を開始する前に正常に摂食できなければならず、母親が保存された乳房の供給を持っていない場合、乳児用調合乳に耐えることができなければなりません研究期間をカバーするのに十分な牛乳
- -参加者は、合計4.5日間（108時間）乳児への授乳を一時的に中止する意思がある必要があります
- 参加者は、研究を通して定期的に乳房をさく乳し、研究期間を通して授乳を維持するように設計されたスケジュールに従って搾乳することをいとわない必要があります
除外基準:
- -スクリーニング時または-1日目のSARS-CoV-2感染の陽性検査結果（RT-PCR）
- 臨床的に重要な所見の証拠または履歴
- -治験薬の初回投与前5日以内の熱性疾患または乳房炎の病歴
- -スクリーニングまたは入学前の7日以内にCOVID-19ワクチンを接種した参加者、または研究制限期間中の任意の時点でCOVID-19ワクチンを接種する予定の参加者
- -HIV感染、B型肝炎、またはC型肝炎の病歴; HIV、HBsAg、またはHCVAbの陽性検査。 B型肝炎ワクチンは許可されています
- 血圧、12誘導心電図などのバイタルサインの異常
- アルコール乱用および/または違法薬物の使用歴、1日5本または1日2噛みを超えるタバコの使用
- 60日以内の献血
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ニルマトレルビル/リトナビル
nirmatrelvir/ritonavir は錠剤として 1 日 2 回経口投与されます
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ニルマトレルビル/リトナビル
他の名前：
ニルマトレルビル/リトナビル
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Body Weight Normalized Maternal Dose (BWNMD) of Nirmatrelvir in mg/kg/Day
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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).
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At Screening (from Day -28 to Day -2) or Day -1
|
協力者と研究者
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年12月12日
一次修了 (実際)
2023年12月15日
研究の完了 (実際)
2023年12月15日
試験登録日
最初に提出
2022年6月28日
QC基準を満たした最初の提出物
2022年6月28日
最初の投稿 (実際)
2022年7月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月1日
QC基準を満たした最後の更新が送信されました
2026年4月28日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- C4671039
- 2022-001020-15 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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