Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
調査の概要
状態
条件
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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Berlin、ドイツ
- 1334.2.1 Boehringer Ingelheim Investigational 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:
- Healthy male subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (BP (blood pressure), PR (pulse rate), 12-lead ECG (electro cardiogramm), and clinical laboratory tests
- Age of 18 to 50 years (incl.)
- BMI (body mass index) of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP(Good Clinical Practice) and local legislation
- Subject is able to understand and communicate in German
Exclusion criteria:
- Any finding in the medical examination (including BP (blood pressure), PR (pulse rate) or ECG (electro cardiogramm) is deviating from normal and judged as clinically relevant by the investigator
- Pulse rate outside 45-80 bpm (beats per minutes) or repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mm Hg
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10 half-lives of the respective drug prior to administration of trial medication
- Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
- Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication
- Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking during inhouse-confinement
- Alcohol abuse (consumption of more 30 g per day for males)
- Drug abuse or positive drug screening
- Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- Vulnerable subjects, e.g. subjects kept in detention, soldiers, employees of the sponsor or a clinical research organization, involved in this study
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: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 |
---|---|
プラセボコンパレーター:プラセボ
|
プラセボ
|
実験的:BI 691751 Dose 1
multiple dose given over 14 days
|
BI 691751 Dose 1
BI 691751 Dose 2
BI 691751 Dose 3
BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
|
実験的:BI 691751 Dose 2
multiple dose given over 14 days
|
BI 691751 Dose 1
BI 691751 Dose 2
BI 691751 Dose 3
BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
|
実験的:BI 691751 Dose 3
multiple dose given over 14 days
|
BI 691751 Dose 1
BI 691751 Dose 2
BI 691751 Dose 3
BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
|
実験的:BI 691751 Dose 4
multiple dose given over 14 days
|
BI 691751 Dose 1
BI 691751 Dose 2
BI 691751 Dose 3
BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
|
実験的:BI 691751 Dose 5
multiple dose given over 14 days
|
BI 691751 Dose 1
BI 691751 Dose 2
BI 691751 Dose 3
BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
|
実験的:BI 691751 Dose 6
multiple dose given over 14 days
|
BI 691751 Dose 1
BI 691751 Dose 2
BI 691751 Dose 3
BI 691751 Dose 4
BI 691751 Dose 5
BI 691751 Dose 6
|
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 |
---|---|---|
Percentage of Subjects With Drug-related Adverse Events
時間枠:From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
|
Percentage of subjects with drug-related Adverse events (AEs)
|
From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)
時間枠:0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
|
AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study. |
0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
|
Cmax (Maximum Measured Concentration of the Analyte Inplasma)
時間枠:0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
|
Cmax (maximum measured concentration of the analyte inplasma). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study. |
0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration
|
AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
時間枠:312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
|
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study. |
312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
|
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)
時間枠:312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t). This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study. |
312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration
|
協力者と研究者
スポンサー
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
本研究に関する用語
その他の研究ID番号
- 1334.2
- 2013-003813-17 (EudraCT番号:EudraCT)
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。
プラセボの臨床試験
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Palacky University完了
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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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Advice Pharma Group srl積極的、募集していない肥満 | 栄養障害 | 体重 | 減量 | 食生活 | 太りすぎと肥満 | 健康行動 | ダイエット、健康 | ダイエット習慣 | ライフスタイル | 栄養、健康 | 行動障害イタリア
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University Hospital, Strasbourg, France積極的、募集していない