Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
2011年11月18日 更新者：Bristol-Myers Squibb
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Subjects and a Comparison to Elderly Male and Female Subjects
The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.
調査の概要
状態
完了
条件
介入・治療
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：BMS-708163 (Gamma-Secretase Inhibitor)
- 薬：Placebo matching BMS-708163
- 薬：Placebo matching BMS-708163
研究の種類
介入
入学 (実際)
116
段階
- フェーズ 1
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年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45
- Panels 9 and 10: healthy elderly males and females ages 60 and greater
- Panel 11: healthy males between the ages of 46-59
- Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74
- Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater
- Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations
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：基礎科学
- 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 |
|---|---|
|
実験的：Panel 1: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 2: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 3: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 4: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 5: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years). In Period 2: Subjects will receive BMS-708163 or placebo as a capsule formulation. In Period 3: Subjects will receive BMS-708163 or placebo as a capsule formulation within 5 minutes of consuming a standard high-fat breakfast on Day 1 |
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 6: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 7: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 8: BMS-708163 or Placebo
Healthy male subjects (age: 18 to 45 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 9: BMS-708163 or Placebo
Healthy, elderly male subjects (age: 60 years and greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 10: BMS-708163 or Placebo
Healthy, elderly female subjects (age: 60 years and greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 11: BMS-708163 or Placebo
Healthy male subjects (age: between 46 to 59 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 12: BMS-708163 or Placebo
Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 13: BMS-708163 or Placebo
Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
|
実験的：Panel 15: BMS-708163 or Placebo
Healthy young male subjects
|
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 1.5 mg, Once daily, once
Oral Solution, Oral, 5.0 mg, Once daily, once
Oral Solution, Oral, 15.0 mg, Once daily, once
Oral Solution, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 100 mg, Once daily, once
Oral Solution, Oral, 200 mg, Once daily, once
Oral Solution, Oral, 400 mg, Once daily, once
Capsule, Oral, 50 mg, Once daily, once
Oral Solution, Oral, 800 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Capsule, Oral, 0 mg, Once daily, once
|
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 |
|---|---|---|
|
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects
時間枠：Within 28 days of dosing
|
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
|
Within 28 days of dosing
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Effects of BMS-708163 on cortisol and QT interval corrected for heart rate
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Effect of food on the PK of BMS-708163 administered as a capsule formulation
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Maximum observed plasma concentration (Cmax) of BMS-708163
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Time of maximum observed plasma concentration (Tmax) of BMS-708163
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
|
Plasma half-life (T-HALF) of BMS-708163
時間枠：Within 28 days of dosing
|
Within 28 days of dosing
|
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
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
2007年6月1日
一次修了 (実際)
2009年3月1日
研究の完了 (実際)
2009年3月1日
試験登録日
最初に提出
2011年10月7日
QC基準を満たした最初の提出物
2011年10月17日
最初の投稿 (見積もり)
2011年10月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2011年11月21日
QC基準を満たした最後の更新が送信されました
2011年11月18日
最終確認日
2011年11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。