A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects
2016年10月25日 更新者:Actelion
A Randomised Double-blind, Placebo-controlled, Ascending Multiple Dose Phase 1 Study of CDP923 in Healthy Volunteers to Assess Safety, Tolerability, Pharmacokinetics and Food Effect
The objectives of this study were to evaluate the safety and tolerability of lucerastat and to determine its pharmacokinetic profile after multiple dosing.
Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.
調査の概要
詳細な説明
The subjects were to be enrolled sequentially to three dose groups, starting with the lowest dose level.
Subjects could participate in only one Group.
Progression to an increased dose of lucerastat was permitted only after review of all data from the previous cohort suggested that it was safe to do so.
研究の種類
介入
入学 (実際)
37
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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Edinburgh、イギリス、EH14 4AP
- Investigator site
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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~45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:
- Signed informed consent form.
- Male subjects aged from 18 to 45 years at screening.
- Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
Exclusion Criteria:
- History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
- Serious adverse reaction or hypersensitivity to any drug.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
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:Cohort 1 (200 mg)
Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
他の名前:
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実験的:Cohort 2 (500 mg)
Six subjects received 500 mg of lucerastat as a single dose in the morning of Day 1 in fed conditions.
After a 5-day washout, they received the same dose twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
他の名前:
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実験的:Cohort 3 (500 mg)
Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
他の名前:
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実験的:Cohort 4 (1000 mg)
Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
他の名前:
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プラセボコンパレーター:Placebo cohorts 1 to 4
Twelve subjects received matched placebo (3 subjects per cohort, except for Cohort 3 where 4 subjects received placebo)
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Placebo capsules matching lucerastat capsules
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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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Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax)
時間枠:PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
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Cmax was used to assess dose proportionality across all dose groups
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
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Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC)
時間枠:PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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AUC from time zero to infinity [AUC(0-inf)] was used to assess dose proportionality across all dose groups
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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Terminal elimination half-life (t1/2)
時間枠:PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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t1/2 was calculated from the plasma concentrations-time curves of lucerastat after multiple doses
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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Food effect on lucerastat pharmacokinetics assessed by Cmax
時間枠:PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing Cmax in fed vs fasted state in the 500 mg cohort (cohort 2)
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PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Food effect on lucerastat pharmacokinetics assessed by AUC
時間枠:PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing AUC in fed versus fasted state in the 500 mg cohort (cohort 2)
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PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Number of participants with adverse events (AEs)
時間枠:From baseline up to Day 14 (end of study)
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An AE was defined as any untoward medical occurrence in a clinical investigation subject, which did not necessarily have a causal relationship with the treatment
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From baseline up to Day 14 (end of study)
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Change from baseline in haematology after multiple doses of lucerastat
時間枠:Up to Day 9
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Up to Day 9
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Change from baseline in clinical chemistry after mutliple doses of lucerastat
時間枠:Up to Day 9
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Up to Day 9
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Change from baseline in heart rate after mutliple doses of lucerastat
時間枠:Up to Day 9
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Up to Day 9
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二次結果の測定
結果測定 |
時間枠 |
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Change from baseline in haematology after a single dose of lucerastat
時間枠:At 24 hours post dose
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At 24 hours post dose
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Change from baseline in clinical chemistry after a single dose of lucerastat
時間枠:At 24 hours post dose
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At 24 hours post dose
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Change from baseline in heart rate after a single dose of lucerastat
時間枠:At 24 hours post dose
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At 24 hours post dose
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Change from baseline in blood pressure after a single dose of lucerastat
時間枠:Up to 24 hours post dose
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Up to 24 hours post dose
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Change from baseline in electrocardiogram (ECG) variables after a single dose of lucerastat
時間枠:Up to 24 hours post dose
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Up to 24 hours post dose
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Stool frequency after multiple doses of lucerastat
時間枠:Every day up to Day 9
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Every day up to Day 9
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Change from baseline in body weight after multiple doses of lucerastat
時間枠:At Day 9
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At Day 9
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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
捜査官
- Nicolas Guérard、Actelion
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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
2003年12月1日
一次修了 (実際)
2004年5月1日
研究の完了 (実際)
2004年5月1日
試験登録日
最初に提出
2016年10月24日
QC基準を満たした最初の提出物
2016年10月25日
最初の投稿 (見積もり)
2016年10月26日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年10月26日
QC基準を満たした最後の更新が送信されました
2016年10月25日
最終確認日
2016年10月1日
詳しくは
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