Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers
2018年12月11日 更新者：Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.
調査の概要
詳細な説明
This study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers.
The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase.
Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women.
Within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days.
The dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment.
This 21-day gap will be applied to all subsequent groups.
Each volunteer will participate in the study for approximately 58 days.
研究の種類
介入
入学 (実際)
80
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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Florida
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Miramar、Florida、アメリカ
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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～60年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2
- Volunteers must be non-diabetic as confirmed by fasting plasma glucose <126 mg/dL
- Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)
Exclusion Criteria:
- History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
- History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
- History of gastric banding, gastric bypass or other gastric-reduction surgery
- History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment
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：ダブル
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：Cohort 1
Each volunteer will receive a total daily dose of 30 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
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A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
他の名前：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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実験的：Cohort 2
Each volunteer will receive a total daily dose of 100 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
他の名前：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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|
実験的：Cohort 3
Each volunteer will receive a total daily dose of 300 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
他の名前：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
実験的：Cohort 4
Each volunteer will receive a total daily dose of 600 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
他の名前：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
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実験的：Cohort 5
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) twice daily (600 mg total daily dose) or placebo (inactive medication) twice daily on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
他の名前：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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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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Change from baseline in urine glucose excretion per day
時間枠：Day -1 (Baseline) up to Day 17
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The change from baseline in urine excretion per day will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 17
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Change from baseline in urine glucose excretion per hour
時間枠：Day -1 (Baseline) up to Day 17
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The change from baseline in urine excretion per hour will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 17
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Visual analog scale (VAS) scores related to hunger, satiety, fullness and prospective food consumption
時間枠：Day -2 up to Day 17
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Visual analog scale (VAS) scores will be obtained from the VAS questionnaire.
In the VAS questionnaire, volunteers mark a point on a line (drawn between 2 statements) to indicate how they feel about the statements.
The statements about hunger are as follows: "I am not hungry at all" and "I have never been hungrier".
Other statements relate to satiety (feeling satisfied), feeling full and prospective food consumption.
Scores will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -2 up to Day 17
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Change from baseline in mean 24-hour plasma glucose concentrations
時間枠：Day -1 (Baseline) up to Day 16
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The change from baseline in mean 24-hour plasma glucose concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 16
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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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Renal threshold for glucose excretion
時間枠：Up to Day 17
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The point at which glucose starts to appear in the urine is known as the renal threshold.
The way in which the renal threshold varies in relation to the dose of canagliflozin (JNJ-28431754) will be calculated.
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Up to Day 17
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Change from baseline in mean 24-hour plasma insulin concentrations
時間枠：Day -1 (Baseline) up to Day 14
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The change from baseline in mean 24-hour plasma insulin concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Change from baseline in mean 24-hour plasma C-peptide concentrations
時間枠：Day -1 (Baseline) up to Day 14
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The change from baseline in mean 24-hour plasma C-peptide concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
|
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Change from baseline in glucose excursions (after breakfast)
時間枠：Day -1 (Baseline) up to Day 14
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Defined as the difference between the maximum glucose values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
|
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Change from baseline in insulin excursions (after breakfast)
時間枠：Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum insulin values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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Change from baseline in beta cell function
時間枠：Day -1 (Baseline) up to Day 14
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Beta cell function will be calculated from the glucose, insulin, and C-peptide measurements taken post-breakfast on Day -1 up to Day 14. Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 14
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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。
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 (実際)
2007年6月14日
一次修了 (実際)
2007年12月5日
研究の完了 (実際)
2007年12月5日
試験登録日
最初に提出
2012年12月20日
QC基準を満たした最初の提出物
2012年12月20日
最初の投稿 (見積もり)
2012年12月25日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月13日
QC基準を満たした最後の更新が送信されました
2018年12月11日
最終確認日
2018年12月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CR013765
- 28431754NAP1008 (その他の識別子：Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
医薬品およびデバイス情報、研究文書
米国FDA規制機器製品の研究
いいえ
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。