18歳以上55歳以下の健康な男性および女性参加者におけるセフチブテンおよびレダボルバクタムの血漿および肺内薬物動態
健康な成人参加者におけるセフチブテンとレダボルバクタムの安全性と血漿および肺内薬物動態を評価するための第 1 相非盲検試験
調査の概要
詳細な説明
In Group 1, participants were to receive a total of five oral doses of ceftibuten ledaborbactam etzadroxil (600 mg ceftibuten/600 mg ledaborbactam etzadroxil) every 12 hours. Following the fifth dose, each participant was to undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five designated timepoints (2, 4, 6, 8, and 12 hours), with five participants assigned to each timepoint.
In Group 2, participants were to receive a total of five doses of 600 mg oral ceftibuten alone every 12 hours. After the last dose, each participant was to undergo one standardized bronchoscopy with BAL at one of two designated timepoints (4 and 12 hours), with three participants assigned to each timepoint.
Blood samples to determine plasma concentrations of ceftibuten, ledaborbactam etzadroxil (Group 1 only), and urea were to be collected at the designated timepoints.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Arizona
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Phoenix、Arizona、アメリカ、85032
- Pulmonary Associates
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
包含基準:
- 18～55歳の健康な成人
- 男性または非妊娠・非授乳中の女性
- BMI: ≥18 かつ ≤32 kg/m2
- 1秒間の努力呼気量が予測値の80%以上
- 定義された開始基準を満たす検査値
除外基準:
- -ペニシリン、セファロスポリン、β-ラクタム系抗菌薬、または気管支鏡検査中に使用される薬剤に対する薬物アレルギーまたは過敏症の病歴
- 経口投与された薬物の吸収および/または排泄を変化させる可能性のある症状
- 過去3か月以内の臨床的に関連する急性疾患または手術を含む重大な疾患の病歴または存在
- アルコール、薬物、またはタバコの使用/検査陽性
研究計画
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：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Group 1
Participants in Group 1 underwent one standardized bronchoscopy with bronchoalveolar lavage after the fifth dose of ceftibuten-ledaborbactam etzadroxil.
|
Five doses of ledaborbactam etzadroxil administered orally every 12 hours
Five doses of ceftibuten administered orally every 12 hours
|
|
実験的：Group 2
Participants in Group 2 underwent one standardized bronchoscopy with bronchoalveolar lavage after the fifth of dose of ceftibuten alone.
|
Five doses of ceftibuten administered orally every 12 hours
|
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 |
|---|---|---|
|
Intrapulmonary PK - AUC0-12 at Steady State in Group 1: Ceftibuten and Ledaborbactam Etzadroxil
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
The PK parameter AUC0-12 for ceftibuten and ledaborbactam etzadroxil was assessed by standardized bronchoscopy with bronchoalveolar lavage (BAL). BAL samples were collected from each participant at one of five designated time points (2, 4, 6, 8, and 12 hours). The first aspirate was collected separately (BAL 1), while the second through the fourth aspirates were pooled (BAL 2). Mean concentration values at each BAL sampling time point were determined, and data from all sampling times were combined into a single dataset to calculate the AUC0-12 value for each matrix. AUC 0-12 was estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF concentration at one time point, so the pharmacokinetic parameters for ELF were calculated using the arithmetic mean concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF across all participants. |
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
|
Plasma Maximum Concentration (Cmax) of Ceftibuten
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
The pharmacokinetic parameter (PK) Cmax of ceftibuten assessed at at steady-state.
|
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
|
Plasma Area Under the Curve From Time Zero to 12 Hours (AUC0-12) for Ceftibuten
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
The PK parameter AUC0-12 for ceftibuten assessed at at steady-state.
|
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
|
Plasma Maximum Concentration (Cmax) of Ledaborbactam Etzadroxil
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
The pharmacokinetic parameter (PK) Cmax of ledaborbactam etzadroxil assessed at at steady-state.
|
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
|
Plasma AUC0-12h for Ledaborbactam Etzadroxil
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
The pharmacokinetic parameter (PK) AUC0-12h of ledaborbactam etzadroxil assessed at at steady-state.
|
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
|
Ratios of Drug Exposure for Ledaborbactam Etzadroxil and Ceftibuten
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
Drug penetration ratio of epithelial lining fluid (ELF) to unbound plasma were assessed using the AUC values for each matrix for BAL 1 and BAL 2. BAL samples were collected from each participant at one of five designated time points (2, 4, 6, 8, and 12 hours). The first aspirate was collected separately (BAL 1), while the second through the fourth aspirates were pooled (BAL 2). All pharmacokinetic parameters (PK) were estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF concentration at one time point, so the PK parameters for ELF were calculated using the arithmetic mean concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF across all participants. |
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
|
Ratios of Drug Exposure for Ceftibuten
時間枠：Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
Drug penetration ratio of epithelial lining fluid (ELF) to unbound plasma were assessed using the AUC values for each matrix for BAL 1 and BAL 2. BAL samples were collected from each participant at one of five designated time points (2, 4, 6, 8, and 12 hours). The first aspirate was collected separately (BAL 1), while the second through the fourth aspirates were pooled (BAL 2). All pharmacokinetic parameters (PK) were estimated using Phoenix WinNonlin Non-compartmental analysis. Each participant only contributed one ELF concentration at one time point, so the PK parameters for ELF were calculated using the arithmetic mean concentration at each BAL sampling time point, resulting in a single parameter estimate of ELF across all participants. |
Samples were taken at 0, 2, 4, 6, 8, and 12 hours post 5th dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) After Administration of Ceftibuten and Ledaborbactam Etzadroxil
時間枠：Up to Day 8
|
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug.
|
Up to Day 8
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Kamal Hamed, MD, MPH、Basilea Pharmaceutica International Ltd, Allschwil
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- VNRX-7145-105
- HHSN272201600029C (その他の助成金/資金番号：National Institute of Allergy and Infectious Diseases)
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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