First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375
Double-blind, Placebo Controlled, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 After Single Oral Administrations Ranging From 0.5 mg to 100 mg in Healthy Male Subjects (Part 1) Followed by the Assessment of the Effect of 3 Single Different BP1.5375 Oral Doses on Polysomnography in Comparison to 50 mg Diphenhydramine and Placebo in Healthy Male Subjects (Part 2).
調査の概要
詳細な説明
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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-
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Leiden、オランダ、2333
- Centre for Human Drug Research
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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:
- Signed informed consent prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 45 years (inclusive).
- Subjects with a body weight of at least 50 kg and a body mass index (BMI) between 18.0 and 28.0 kg/m2 (both inclusive).
- Healthy subjects, based on history, physical examination, complete laboratory evaluation, and 12-lead ECG.
- Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the investigator. Normal BP to be [100-140] mmHg systolic and [45-90] mmHg diastolic. Normal pulse rate to be [40-90] bpm after 5 minutes rest in lying position.
Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Exclusion Criteria:
- Subject with a history of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease, or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject, or impact the validity of the study results.
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Haematology, clinical chemistry, and urinalysis results deviating from the normal range to a clinically relevant extent at screening.
- Clinically significant findings on physical examination at screening.
- 12-lead electrocardiogram (ECG) with clinically relevant abnormalities in supine position at screening.
- Positive results from urine drug screen at screening.
- Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access or puncture, or veins with a tendency for rupture during or after puncture).
- Treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort) within 2 weeks prior to the (first) scheduled administration of study drug, except paracetamol (maximum 1 g/day).
- Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
- Have undergone surgery or have donated an amount equal or more than 500 mL blood, or 300 mL of plasma, within 3 months prior to screening.
- Positive results from any of the hepatitis serology tests (HBsAg, anti-HCV), at screening.
- Positive results from the HIV 1 or/and 2 serology at screening.
- History of allergy to diphenhydramine or antihistaminic drugs.
- Smoking more than 5 cigarettes per day.
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 |
---|---|
プラセボコンパレーター:プラセボ
単回経口投与
|
単回経口投与
single oral dose
single oral dose of Diphenhydramine 50mg
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実験的:BP1.5375
Single oral administration ranging from 0.5 mg to 100 mg
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単回経口投与
single oral dose
single oral dose of Diphenhydramine 50mg
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アクティブコンパレータ:Diphenhydramine
Single oral dose of diphenhydramine 50mg
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単回経口投与
single oral dose
single oral dose of Diphenhydramine 50mg
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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 |
メジャーの説明 |
時間枠 |
---|---|---|
Single Ascending Dose - safety and tolerability (Part 1)
時間枠:Study period and follow up visit will be no more than 5 weeks
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To determine the clinical and biological safety and tolerability of BP1.5375 after an oral increasing single dose administration BP1.5375.
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Study period and follow up visit will be no more than 5 weeks
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Proof of Concept - effect on polysomnography (Part 2)
時間枠:Study period and follow up visit will be no more than 9 weeks
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To determine whether an BP1.5375 single oral dose induced an effect on polysomnography in healthy male subjects compared to diphenhydramine 50 mg and matching placebo. Safety and tolerability : Monitoring for the occurrence of AEs, changes in physical examination, vital signs (body temperature, lying and standing blood pressure and heart rate), ECG, and clinical laboratory tests. Assessments will be performed at the following time points :
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Study period and follow up visit will be no more than 9 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:van Gerven Joop, MD、Centre for Human Drug Research
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。
プラセボの臨床試験
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Palacky University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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Universidade Federal do ParaConselho Nacional de Desenvolvimento Científico e Tecnológico完了
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University Hospital, Strasbourg, France積極的、募集していない