A Study in Healthy Men to Test Whether BI 474121 Can Reverse the Memory Problems Caused by Ketamine
A Randomized, Placebo Controlled, Double-blind, Double-dummy, Three-way Crossover Trial to Investigate the Effect of Two Doses of BI 474121 on Ketamine Induced Cognitive Deficits in Healthy Male Subjects
調査の概要
研究の種類
段階
- フェーズ 1
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 assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Age of 18 to 55 years (inclusive)
- Body mass index (BMI) of 18.5 to 32 kg/m2 (inclusive)
- Signed and dated written informed consent(s) prior to admission to the study, in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- If men who are able to father a child, are willing to participate, they have to use an adequate form of effective contraception for the duration of study participation and for at least 30 days after treatment has ended
Exclusion Criteria:
- Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm evaluated as clinically significant by Investigators
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
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: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:Treatment sequence T1-T2-R
T1: Lower dose of BI 474121 and higher dose of placebo followed by intravenous ketamine infusion T2: Higher dose of BI 474121 and lower dose of placebo followed by intravenous ketamine infusion R: Lower dose of placebo and higher dose of placebo followed by intravenous ketamine infusion
|
プラセボ
BI 474121
Ketamine hydrochloride
|
|
実験的:治療順序 T2-T1-R
|
プラセボ
BI 474121
Ketamine hydrochloride
|
|
実験的:治療順序 T1-R-T2
|
プラセボ
BI 474121
Ketamine hydrochloride
|
|
実験的:治療順序 T2-R-T1
|
プラセボ
BI 474121
Ketamine hydrochloride
|
|
実験的:治療順序 R-T1-T2
|
プラセボ
BI 474121
Ketamine hydrochloride
|
|
実験的:Treatment sequence R-T2-T1
|
プラセボ
BI 474121
Ketamine hydrochloride
|
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 |
|---|---|
|
Difference between the total number of errors adjusted for stages that subjects did not complete in the paired associate learning test (PALTEA28), post-ketamine minus the PALTEA28 pre-ketamine
時間枠:up to 22 days
|
up to 22 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Difference between the between errors in the spatial working memory test (SWMBE468), post-ketamine minus the SWMBE468 pre-ketamine
時間枠:up to 22 days
|
up to 22 days
|
|
Difference between the Rapid Visual Information Processing test A' (RVPA), post-ketamine minus the RVPA pre-ketamine
時間枠:up to 22 days
|
up to 22 days
|
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 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 1411-0003
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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