Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
2017年4月14日 更新者：Eisai Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.
調査の概要
研究の種類
介入
入学 (実際)
16
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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Fukuoka、日本
- Eisai Trial 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
50年～85年 (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:
- Healthy males and females
- Aged 50 to 85 years, inclusive at time of consent
- Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m^2) at Screening
Exclusion Criteria:
- Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
- A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
- Any clinically significant findings on neurological examination
- A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
- History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
- A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection)
- A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
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：トリプル
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：E2609 50 mg
Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days.
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tablet
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プラセボコンパレーター：Placebo
Participants will receive matching placebo orally once a day for 14 days.
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タブレット
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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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Number of participants with any serious adverse event and number of participants with any non-serious adverse event
時間枠：up to Day 35 (Termination/Visit 5)
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An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
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up to Day 35 (Termination/Visit 5)
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Number of participants with an abnormal, clinically significant laboratory test value
時間枠：Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
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Laboratory test values will be assigned a low/normal/high (LNH) classification according to whether the value was below (L), within (N), or above (H) the laboratory parameter's reference range.
Clinical significance will be determined by the Investigator.
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Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
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Number of participants with an abnormal, clinically significant vital sign value
時間枠：Screening; Baseline; up to Day 62
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Vital sign measurements (ie, systolic and diastolic blood pressure [BP] [millimeters of mercury (mmHg)], heart rate [beats per minute], respiratory rate [breaths per minute], body temperature [centigrade]) will be obtained in the supine position by a validated method.
Clinical significance will be determined by the Investigator.
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Screening; Baseline; up to Day 62
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Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
時間枠：Screening; Baseline; up to Day 62
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Twelve-lead standard ECGs will be recorded in triplicate.
ECGs will be recorded after the participant has been in the supine position for at least 10 minutes before and during the reading.
In addition, all ECGs will be obtained before blood draws.
Clinical significance will be determined by the Investigator.
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Screening; Baseline; up to Day 62
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Clinical assessment of suicidality per the suicidality rating scale
時間枠：Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
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The suicidality rating scale will rate a participant's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
The decision to classify an isolated suicidality rating scale response as an adverse event will be exercised through medical and scientific judgment.
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Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
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Mean quality of sleep score per the Waketime Questionnaire, if necessary
時間枠：up to Day 62
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Participants reporting adverse events (AEs) relating to abnormal dreams, nightmares, or sleep terrors will be questioned using the Waketime Questionnaire which is comprised of 5 individual questions.
A participant is asked to rate the quality of their sleep as: 1, Very sound or restful; 2, Sound or restful; 3, Average quality; 4, Restless; or 5, Very restless.
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up to Day 62
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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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Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
時間枠：Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmax.
Cmax will be summarized as the mean and standard deviation for all participants.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
時間枠：Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Cmin is defined as the minimum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmin.
Cmin will be summarized as the mean and standard deviation for all participants.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
時間枠：Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Tmax.
Tmax will be summarized as the median for all participants.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
時間枠：Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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AUC represents the total drug exposure over a defined period of time.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC(0-24h).
AUC(0-24h) will be summarized as the mean and standard deviation for all participants and will be expressed in nanograms x hour per milliliter (ng*hr/mL).
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
時間枠：Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Terminal half-life is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine t1/2.
t1/2 will be summarized as the mean and standard deviation for all participants and will be expressed in hours.
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Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Mean average concentration calculated as AUCss/tau (Css,av), where tau is the dosing interval, of E2609 and metabolites on Day 1 and Day 14
時間枠：Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Css,av is the average steady-state concentration of a drug.
Steady state will be achieved when the rate of E2609 administration and the rate of E2609 elimination are equal.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine the Css,av.
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
時間枠：Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Rac is equal to the ratio of the AUC during a dosage interval at steady state to the AUC of a dosage interval after the first dose.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine Rac.
Rac will be summarized as the mean and standard deviation for all participants
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Apparent clearance at steady state (CLss/F) of E2609 on Day 14
時間枠：Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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CLss/F is the rate and extent of absorption and clearance of E2609 from the plasma.
Plasma concentrations of E2609 and metabolites will be analyzed using a non-compartmental analysis approach to determine CLss/F.
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Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
時間枠：Day 1
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NAT2 genotyping will be conducted, and the predicted phenotype (eg, slow, intermediate, or rapid acetylators) will be used in the statistical analysis to evaluate the relative impact of NAT2 polymorphisms on plasma concentrations of E2609 and/or its metabolites.
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Day 1
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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)
2017年2月14日
一次修了 (実際)
2017年3月29日
研究の完了 (実際)
2017年4月11日
試験登録日
最初に提出
2017年2月10日
QC基準を満たした最初の提出物
2017年2月14日
最初の投稿 (実際)
2017年2月16日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月18日
QC基準を満たした最後の更新が送信されました
2017年4月14日
最終確認日
2017年4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。
プラセボの臨床試験
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