A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Administration of Multiple Ascending Doses for 8 Days in Healthy Male or Female Subjects
The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects.
AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.
調査の概要
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
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London Bridge、イギリス
- Research Site
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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:
- Provision of signed and dated, written informed consent
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
- Healthy male or female (of non child bearing potential)volunteers with suitable veins for cannulation or repeated venepuncture
Exclusion Criteria:
- Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate
- Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
- Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
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
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
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実験的：1
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oral suspension dose of AZD5069.
Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
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プラセボコンパレーター：2
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oral suspension dose of matched placebo.
Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7
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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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Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry
時間枠：Baselines assessments at Visit 1 (enrolment) or pre-dose on Day 1 with assessments during Visit 2 at protocol defined time-points post-dose until 96hr post final dose. Follow up assessments at Visit 3
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Baselines assessments at Visit 1 (enrolment) or pre-dose on Day 1 with assessments during Visit 2 at protocol defined time-points post-dose until 96hr post final dose. Follow up assessments at Visit 3
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Pharmacokinetic profile: concentration of AZD5069 in blood
時間枠：Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood
時間枠：Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Measurement of the effect of AZD5069 on blood cells
時間枠：Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Darren Wilbraham, MBBS, DCPSA、Quintiles, Inc.
出版物と役立つリンク
便利なリンク
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
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。