A Study in Japanese Healthy Men to Test How Well Different Doses of BI 3031185 Are Tolerated and a Study in Japanese Healthy Women to Test Whether BI 3031185 Influences the Amount of a Contraceptive in the Blood
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of BI 3031185 in Japanese Healthy Male Trial Participants (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and Effect of Multiple Doses of BI 3031185 on Pharmacokinetics of a Single Dose of a Combination of Drospirenone and Ethinylestradiol (Oral Contraceptive) in Japanese Healthy Female Trial Participants (Non-randomised, Open-label, Fixed Sequence Design)
Single dose (SD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of single dose.
Multiple doses (MD) part: The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male trial participants following oral administration of multiple doses.
Oral contraceptives (OC) part: The main objective of this trial is to investigate the effect of multiple oral doses of BI 3031185 on pharmacokinetics of drospirenone (DRSP) and ethinylestradiol (EE) (YAZ®) in Japanese healthy female trial participants.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Boehringer Ingelheim
- 電話番号：1-800-243-0127
- メール：clintriage.rdg@boehringer-ingelheim.com
研究場所
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Fukuoka, Fukuoka、日本、813-0017
- Fukuoka Mirai Hospital
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コンタクト：
- Boehringer Ingelheim
- 電話番号：05050508862
- メール：nippon@bitrialsupport.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion criteria:
Single dose (SD) and multiple doses (MD) part: Healthy male trial participant 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 Oral contraceptives (OC) part: Women of non-childbearing potential (WONCBP) who meet postmenopausal or surgically sterilised according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Postmenopausal, defined as no menses for 1 year without an alternative medical cause.
- Surgically sterilised (including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
- SD and MD part: Age of 18 to 45 years (inclusive) OC part: Age of 18 to 64 years (inclusive)
- Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 40 to 89 mmHg, or pulse rate outside the range of 45 to 99 bpm
- 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 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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SD part: BI 3031185
SD = Single dose
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BI 3031185
|
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実験的：SD Part: Placebo matching BI 3031185
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Placebo matching BI 3031185
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実験的：MD part: Midazolam and BI 3031185
MD = Multiple doses
|
ミダゾラム
他の名前：
BI 3031185
|
|
実験的：MD Part: Midazolam and Placebo matching BI 3031185
|
ミダゾラム
他の名前：
Placebo matching BI 3031185
|
|
実験的：OC part: YAZ® and BI 3031185
OC = Oral contraceptives
|
BI 3031185
YAZ®
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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 |
|---|---|---|
|
SD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
時間枠：Up to 29 days
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SD = Single dose
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Up to 29 days
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MD part: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
時間枠：Up to 47 days
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MD = Multiple doses
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Up to 47 days
|
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OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
時間枠：Up to 29 days
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OC = Oral contraceptives
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Up to 29 days
|
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OC part: Maximum measured concentration of the analyte in plasma (Cmax)
時間枠：Up to 29 days
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Up to 29 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
SD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
時間枠：Up to 11 days
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Up to 11 days
|
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SD part: Maximum measured concentration of the analyte in plasma (Cmax)
時間枠：Up to 11 days
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Up to 11 days
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MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
時間枠：Up to 39 days
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Up to 39 days
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MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
時間枠：Up to 39 days
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Up to 39 days
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OC part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
時間枠：Up to 29 days
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Up to 29 days
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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 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- 1516-0005
- U1111-1331-6622 (レジストリ識別子：WHO International Clinical Trials Registry Platform (ICTRP))
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:
https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
ミダゾラムの臨床試験
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Polish Mother Memorial Hospital Research Instituteまだ募集していません
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The First Affiliated Hospital of Xiamen University積極的、募集していない
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University of CologneUmm Al-Qura University完了