A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
2010年1月5日 更新者:Pfizer
A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects
The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.
調査の概要
研究の種類
介入
入学 (実際)
24
段階
- フェーズ 4
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
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Connecticut
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Hartford、Connecticut、アメリカ、06102
- Pfizer Investigational Site
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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
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy adult subjects willing to comply with the study requirement.
Exclusion Criteria:
- Clinical significant disease.
- Sensitive to study medication.
- Not willing to comply with the study requirement.
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
- 割り当て:ランダム化
- 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:1
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Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.
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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 |
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Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
時間枠:100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Cmax = maximum observed plasma concentration; measured in micrograms per milliliter (ug/mL).
Observed directly from the data.
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)
時間枠:100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
|
Tmax = time (hours) to maximum plasma concentration (Cmax).
Observed directly from data as time of first occurrence.
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)
時間枠:100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole; measured as micrograms times hours per milliliter (ug*hr/mL).
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Plasma Elimination Half-life (t1/2)
時間枠:100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Total Clearance (CL Total)
時間枠:100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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CL total = total clearance calculated as dose divided by AUCt; measured as milliliters per minute (mL/min).
Collected on Day 3.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Plasma PK: Volume of Distribution at Steady-state (Vss)
時間枠:100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Vss = volume of distribution at steady-state; measured as liters (L).
Calculated as (CL multiplied by mean residence time extrapolated to infinity [MRTinf]).
MRTinf = [(AUMCt plus t (AUCinf minus AUCt)) divided by AUCt] minus (infusion time divided by 2); AUMCt = area under the first moment curve from time zero to time t; AUCinf = area under the plasma concentration-time curve extrapolated to infinity.
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100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion
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Epithelial Lining Fluid (ELF) PK: Cmax
時間枠:4, 8, 12, 24 hours after start of infusion
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Cmax=maximum observed plasma concentration.
ELF collected by bronchoscopy and bronchoalveolar lavage (BAL) Day 3; determined from BAL sample using urea dilution method: [Drug ELF]=[Drug BAL] multiplied by [Urea SERUM] divided by [Urea BAL].
Drug ELF=anidulafungin or voriconazole (drug) concentration in ELF corrected for dilution; Drug BAL=assayed drug concentration in BAL; Urea SERUM and Urea BAL simultaneously collected.
Summary parameters derived using average data for all subjects; associated to a single subject for reporting purposes (mean with standard deviation not calculated).
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4, 8, 12, 24 hours after start of infusion
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ELF PK: Tmax
時間枠:4, 8, 12, 24 hours after start of infusion
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Tmax = time (hours) to maximum plasma concentration (Cmax).
Observed directly from data as time of first occurrence.
ELF collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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ELF PK: AUCtau
時間枠:4, 8, 12, 24 hours after start of infusion
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AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole.
ELF collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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ELF PK: t1/2
時間枠:4, 8, 12, 24 hours after start of infusion
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t1/2 = terminal elimination half-life in hours; Loge(2)/Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
ELF collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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Alveolar Macrophages (AM): Cmax
時間枠:4, 8, 12, 24 hours after start of infusion
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Cmax = maximum observed plasma concentration; observed directly from the data.
AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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AM: Tmax
時間枠:4, 8, 12, 24 hours after start of infusion
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Tmax = time (hours) to maximum plasma concentration (Cmax).
Observed directly from data as time of first occurrence.
AM collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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AM: AUCtau
時間枠:4, 8, 12, 24 hours after start of infusion
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AUCtau = area under the plasma concentration-time profile from time zero (0) to time = t (AUCt), the dosing interval, where t is 24 hours for anidulafungin and 12 hours for voriconazole.
AM collected by bronchoscopy and BAL on Day 3. Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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AM: t1/2
時間枠:4, 8, 12, 24 hours after start of infusion
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t1/2 = terminal elimination half-life in hours; Loge(2)Kel, where Kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
AM collected by bronchoscopy and BAL on Day 3.
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4, 8, 12, 24 hours after start of infusion
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Overall Drug Penetration Ratio in ELF
時間枠:4, 8, 12, 24 hours after start of infusion
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ELF collected by bronchoscopy and BAL on Day 3. ELF to plasma penetration ratio calculated by dividing area under the plasma concentration-time profile (AUC) in ELF by AUC in plasma from 20 subjects where t is 24 hours for anidulafungin and 12 hours for voriconazole.
Summary parameters were derived using average data for all subjects and associated to a single subject for reporting purposes (mean with standard deviation was not calculated).
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4, 8, 12, 24 hours after start of infusion
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Concentration Ratio in ELF to Plasma
時間枠:4, 8, 12, 24 hours after start of infusion
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Concentration ratio in ELF to plasma determined by a point estimate within each subject at the time-point where ELF data was available.
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4, 8, 12, 24 hours after start of infusion
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2008年9月1日
一次修了 (実際)
2008年10月1日
研究の完了 (実際)
2008年10月1日
試験登録日
最初に提出
2009年7月13日
QC基準を満たした最初の提出物
2009年7月14日
最初の投稿 (見積もり)
2009年7月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2010年2月9日
QC基準を満たした最後の更新が送信されました
2010年1月5日
最終確認日
2010年1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
- A8851020
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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