Pharmacodynamic and Pharmacokinetic Study of 2 Different Dose Regimen of Clopidogrel in CYP2C19 Genotyped Healthy Subjects
A Randomized, Double-blind, Double-dummy, Two Period, Two Treatment Cross-over Pharmacodynamic and Pharmacokinetic Study of Clopidogrel Given as 5-day Repeated Oral Doses (300 mg Loading Dose Followed by 75 mg/Day and 600 mg Loading Dose Followed by 150 mg/Day) in 4 Different Groups of CYP2C19 Genotyped Healthy Male and Female Subjects
Primary Objective:
- Investigate the possible role of the CYP2C19 genotype in Adenosine diphosphate (ADP)-induced platelet aggregation after administration of a standard dose regimen of clopidogrel (300 mg loading dose followed by 75 mg/day for 4 days) in healthy male and female subjects
Secondary Objectives:
- Assess the pharmacodynamic activity of a higher dose regimen of clopidogrel (600 mg loading dose followed by 150 mg/day for 4 days)
- Compare the pharmacokinetic profiles of clopidogrel active metabolite between the selected groups of genotyped subjects and the 2 dose regimen
調査の概要
詳細な説明
The total study duration per subject is 10-12 weeks broken down as follows:
- Screening: 2 to 40 days before the first dosing
- Period 1: 7 days including 5 days treatment
- Washout: At least 14 days after the last dosing
- Period 2: 7 days including 5 days treatment
- End of study: 7 to 10 days after the last dosing
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
-
-
-
Berlin、ドイツ
- Sanofi-Aventis Administrative Office
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
Healthy subject in good health, as determined by a medical history, physical examination including vital signs and clinical laboratory tests:
- with a body weight between 45 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²
classified into one of the 4 groups of metabolizers according to his/her CYP2C19 genotype:
- Ultrarapid Metabolizers (UMs, CYP2C19*1/*17 and CYP2C19*17/*17)
- homozygous Extensive Metabolizers (homoEMs, CYP2C19*1/*1)
- heterozygous Extensive Metabolizers (heteroEMs, CYP2C19*1/*2 and CYP2C19*1/*3)
- Poor Metabolizers (PMs, CYP2C19*2/*2 and CYP2C19*2/*3)
Exclusion criteria:
- Evidence of inherited disorder of coagulation/hemostasis functions
- Subject smoking more than 10 cigarettes or equivalent per day
- Unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sequence clopidogrel 300/75 mg - 600/150 mg
Period 1:
Period 2:
Each intake is at around 8:00 AM fasted for at least 10 hours |
Pharmaceutical form: tablets Route of administration: oral
他の名前：
Pharmaceutical form: matching tablets Route of administration: oral |
|
実験的：Sequence clopidogrel 600/150 mg - 300/75 mg
Period 1:
Period 2:
Each intake is at around 8:00 AM fasted for at least 10 hours |
Pharmaceutical form: tablets Route of administration: oral
他の名前：
Pharmaceutical form: matching tablets Route of administration: oral |
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 |
|---|---|
|
Maximum platelet aggregation intensity (MAI) induced by Adenosine diphosphate (ADP) 5 µM after 5 days treatment
時間枠：Day 5 of each period
|
Day 5 of each period
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Maximum platelet aggregation intensity (MAI) induced by ADP 20 µM after 5 days treatment
時間枠：Day 5 of each period
|
Day 5 of each period
|
|
Platelet reactivity index -Vasodilator-stimulated phosphoprotein test (PRI-VASP) after 5 days treatment
時間枠：Day 5 of each period
|
Day 5 of each period
|
|
Clopidogrel active metabolite pharmacokinetic parameters (Cmax, tmax, AUC0-24, AUClast) after 5 days treatment
時間枠：Up to 24 hours postdose on Day 5 for each period
|
Up to 24 hours postdose on Day 5 for each period
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：International Clinical Development Study Director、Sanofi
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
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PKD11147
- 2009-010105-37 (EudraCT番号)
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。