A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
2016年3月1日 更新者：Pfizer
A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of Pf-06427878 Co Administered With And Without Food In Healthy Adult Subjects
PF-06427878 is a new compound proposed for the treatment of hyperlipidemia.
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06427878 in healthy adult subjects.
調査の概要
研究の種類
介入
入学 (実際)
40
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
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Brussels、ベルギー、B-1070
- Pfizer Clinical Research Unit
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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
受講資格のある性別
全て
説明
Inclusion Criteria:
- Healthy male and/or female subjects of non childbearing potential.
- Body Mass Index (BMI) of 17.5 to 35.4 kg/m2; and a total body weight >50 kg
- Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast
- Subjects with low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL following an overnight fast
Exclusion Criteria:
•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
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：基礎科学
- 割り当て：ランダム化
- マスキング：トリプル
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：Cohort 1
Single dose level of PF-06427878 at 5 mg or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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実験的：Cohort 2
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 1 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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実験的：Cohort 3
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 2 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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実験的：Cohort 4
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 3 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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実験的：Cohort 5
Single dose level of PF-06427878 at a dose no more than 3.5-fold increase from Cohort 4 or placebo every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
|
PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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実験的：Cohort 6
Single dose level of PF-06427878 (with the same total daily dose as Cohort 5) or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
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PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
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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 |
時間枠 |
|---|---|
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Assessment of adverse events (AEs).
時間枠：0-25 days
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0-25 days
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Assessment of clinical laboratory tests.
時間枠：0-25 days
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0-25 days
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Assessment of vital signs (including blood pressure and pulse rate).
時間枠：0-25 days
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0-25 days
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Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
時間枠：0-25 days
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0-25 days
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 1
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 12
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Area Under the Curve for PF-06427878 during the dosing interval (AUCtau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Plasma Decay Half-Life (t1/2) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Volume of Distribution (Vz/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Apparent Oral Clearance (CL/F) of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Minimum Observed Plasma Concentration (Cmin) for PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Peak:Trough ratio of PF-06427878 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1
時間枠：0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12 hours post dose
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Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day14 relative to day 1 during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day14 relative to day 1
時間枠：0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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0, 1, 2, 3, 4, 6, 8, 12, 24 hours post dose
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Amount of PF-06427878 excreted in urine (Ae) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0- tau hours post dose
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0- tau hours post dose
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Percent of dose excreted in urine as PF-06427878 (Ae%) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0- tau hours post dose
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0- tau hours post dose
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Renal clearance of PF-06427878 (CLr) during the dosing interval (tau), ie, 0-8H for Q8H, 0-12H for Q12H, and 0-24H for QD, on day 14
時間枠：0- tau hours post dose
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0- tau hours post dose
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協力者と研究者
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出版物と役立つリンク
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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
2015年3月1日
一次修了 (実際)
2016年2月1日
研究の完了 (実際)
2016年2月1日
試験登録日
最初に提出
2015年3月12日
QC基準を満たした最初の提出物
2015年3月12日
最初の投稿 (見積もり)
2015年3月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年3月2日
QC基準を満たした最後の更新が送信されました
2016年3月1日
最終確認日
2016年3月1日
詳しくは
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。