A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
2015年10月21日 更新者：Galapagos NV
A Phase I, Open Interaction Study Between Oral Doses of GLPG1837 and Single Doses of Midazolam in Healthy Male Subjects
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).
Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.
A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.
調査の概要
研究の種類
介入
入学 (実際)
24
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Antwerp、ベルギー
- SGS LSS Clinical Pharmacology Unit Antwerp
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～50年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
男
説明
Inclusion Criteria:
- healthy male, age 18-50 years
- BMI between 18-30 kg/m2
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Midazolam and 500 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (250 mg b.i.d daily for 10 days) from Days 2 to 11.
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Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
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実験的：Midazolam and 1000 mg GLPG1837
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12) and multiple oral doses of GLPG1837 (500 mg b.i.d daily for 11 days) from Days 2 to 12.
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Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.
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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 |
|---|---|---|
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The maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
時間枠：Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the maximum observed concentration (Cmax) of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
時間枠：Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the time of occurrence of Cmax (tmax) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple oral doses of GLPG1837
時間枠：Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the area under the plasma concentration versus time curve (AUC) of (1'-OH) Midazolam before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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The apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple oral doses of GLPG1837
時間枠：Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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To characterize the apparent terminal half-life (t1/2) of (1'-OH) Midazolam in plasma before and after multiple doses of GLPG1837 in healthy male subjects
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Between Day 1 (predose) and Day 13 (24h post last dose on Day 12)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
時間枠：Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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Number of adverse events
時間枠：Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of the number of adverse events reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature
時間枠：Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in 12-lead ECG measures
時間枠：Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in physical exam measures
時間枠：Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in physical examination reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in blood safety lab parameters
時間枠：Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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Changes in urine safety lab parameters
時間枠：Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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To evaluate the safety and tolerability of GLPG1837 after multiple oral doses in healthy male subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported
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Between Screening and 7-10 days after the last dose of GLPG1837 on Day 12
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The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
時間枠：Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
|
To characterize the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
|
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
|
|
The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
時間枠：Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
|
To characterize the area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
|
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
|
|
The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
時間枠：Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
|
To characterize the apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
|
Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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The metabolite to GLPG1837 ratios in plasma after multiple oral doses of GLPG1837 (and co-administration of Midazolam on Day 12)
時間枠：Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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To characterize the metabolite to GLPG1837 ratios in plasma after multiple doses of GLPG1837 (and co-administration of Midazolam on Day 12) in healthy male subjects
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Between Day 5 (predose) and Day 14 (48h after the last dose on Day 12)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年9月1日
一次修了 (実際)
2015年10月1日
研究の完了 (実際)
2015年10月1日
試験登録日
最初に提出
2015年9月23日
QC基準を満たした最初の提出物
2015年9月27日
最初の投稿 (見積もり)
2015年9月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月23日
QC基準を満たした最後の更新が送信されました
2015年10月21日
最終確認日
2015年10月1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。