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A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants

2017年11月17日 更新者:Janssen Research & Development, LLC

A Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Subjects

The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of JNJ-61393215 in plasma after multiple consecutive dose administrations.

調査の概要

状態

完了

条件

研究の種類

介入

入学 (実際)

71

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

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~55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

説明

Inclusion Criteria:

  • Healthy male participants between 18 and 55 years of age, inclusive
  • Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height square)
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG [incl. QTcF less than or equal to [<=] 450 milliseconds (msec) for males] performed at screening and admission to the clinical unit. Minor abnormalities in electrocardiogram (ECG), which are not considered to be of clinical significance by the investigator, are acceptable. The presence of Left Bundle Branch Block (LBBB), AV Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
  • Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the Participant may be included only if the investigator judges the abnormalities to be not clinically significant. This determination must be recorded in the Participant's source documents and initialed by the investigator
  • A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of contraception e.g., either condom with spermicidal foam/gel/film/cream/suppository during the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug. All men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partner should also use a highly effective method of contraception for at least the same duration. Examples of highly effective contraceptives include implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); vasectomized partner; sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.), combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, and transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral and injectable.
  • Participants must be willing to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable
  • Current or past history of any psychiatric disorder as classified according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or DSM-V, with the exclusion of an anxiety disorder (i.e., panic disorder with or without agoraphobia, social anxiety disorder, and generalized anxiety disorder)
  • Participant has any liver function test (including alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyltransferase [gGT], alkaline phosphatase [ALP and bilirubin] at screening exceeding the upper limit of normal
  • Participant has estimated glomerular filtration rate (eGFR) <60 milliliter per minute (mL/min)/1.73m^2 at screening (provided by the local laboratory)
  • Participant has a heart rate < 50 beats per minute (bpm) or > 100 bpm or systolic blood pressure greater than or equal to (>=) 150 millimeter of mercury (mmHg) at screening or at admission to the clinical unit

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:他の
  • 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
実験的:JNJ-61393215 (Multiple Ascending Dose Phase)
Participants will receive JNJ- 61393215 once daily for 7 days. 4 sequential cohorts will be enrolled to evaluate escalating doses which will be defined, based on safety, tolerability and pharmacokinetic (PK) data from the preceding cohorts. Dose adjustment/selection (increase/decrease) for the next cohort will be based on the JNJ- 61393215 PK profile up to and including the last day of dosing (24 hours postdose) and the safety and tolerability profile of the current cohort.
Participants will receive JNJ-61393215 for 7 days.
プラセボコンパレーター:Placebo (Multiple Ascending Dose Phase)
Participants will receive JNJ- 61393215 matching placebo for 7 days.
Participants will receive JNJ- 61393215 matching placebo for 7 days.

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
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
時間枠:up to 4 weeks
up to 4 weeks
Time To Reach The Maximum Plasma Concentration (Tmax)
時間枠:Day 1
Tmax is time to reach the maximum plasma concentration.
Day 1
Maximum Plasma Concentration (Cmax)
時間枠:Day 1
Cmax is maximum plasma concentration.
Day 1
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
時間枠:Day 1
AUC[0-24] is area under the plasma concentration- time curve from time [0 to 24].
Day 1
The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
時間枠:Days 2 to 6
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Days 2 to 6
The Observed Plasma Concentration Just Prior To the Beginning or at the End of a Dosing Interval of any Dose Other Than the First Dose (Ctrough)
時間枠:Day 7
Ctrough is the observed plasma concentration just prior to the beginning or at the end of a dosing interval of any dose other than the first dose.
Day 7
Minimum Observed Plasma Concentration During Dosing Interval (tau) (Cmin)
時間枠:Day 7
Cmin is minimum observed plasma concentration during dosing interval (tau).
Day 7
Time To Reach The Maximum Plasma Concentration (Tmax)
時間枠:Day 7
Tmax is time to reach the maximum plasma concentration.
Day 7
Maximum Plasma Concentration (Cmax)
時間枠:Day 7
Cmax is maximum plasma concentration.
Day 7
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
時間枠:Day 7
AUC[0-24] is Area under the plasma concentration- time curve from time [0 to 24].
Day 7
Average Plasma Concentration at Steady State Over the Dosing Interval (Cavg)
時間枠:Day 7
Cavg is average plasma concentration at steady state over the dosing interval.
Day 7
Fluctuation Index (FI)
時間枠:Day 7
Fluctuation Index is defined as percentage of fluctuation, calculated as: 100*([Cmax-Cmin]/Cavg).
Day 7
Total Apparent Oral Clearance, Calculated as Dose/AUCtau at Steady-State (CL/F)
時間枠:Day 7
CL/F is total apparent oral clearance, calculated as dose/AUCtau at steady-state.
Day 7
Apparent Terminal Elimination Rate Constant, Determined By Linear Regression of the Terminal Points of the Ln-Linear Plasma Concentration-Time Curve (Lambda[Z])
時間枠:Day 7
Lambda[Z] is apparent terminal elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
Day 7
Apparent Elimination Half-Life Associated With The Terminal Slope of The Semilogarithmic Drug Concentration-Time Curve, After Multiple-Dose Administration Only (t1/2term)
時間枠:Day 7
T1/2term is apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, after multiple-dose administration only.
Day 7
Ratio of Maximum Plasma Concentration (Cmax) Test (Day 7 [steady-state]/ref (Day 1) (Ratio Cmax,test/ref)
時間枠:Day 7
Ratio Cmax,test/ref is ratio of maximum plasma concentration (Cmax) test (day 7 [steady-state]/ref (day 1).
Day 7
Ratio of Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24]) Test (Day 7 [steady-state]/ref (Day 1) (Ratio AUC24h,test/ref)
時間枠:Day 7
Ratio AUC24h,test/ref is ratio of area under the plasma concentration- time curve from time [0 to 24] (AUC[0-24]) test (day 7 [steady-state]/ref (day 1).
Day 7

二次結果の測定

結果測定
メジャーの説明
時間枠
Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale
時間枠:Day 1 and Day 7
Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end. The Bond-Lader of a 10 cm line. Participants will rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item is scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria are then calculated from the combined scores of selected items. The score ranges from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Day 1 and Day 7

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。

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1月1日

一次修了 (実際)

2017年10月1日

研究の完了 (実際)

2017年10月1日

試験登録日

最初に提出

2016年12月30日

QC基準を満たした最初の提出物

2016年12月30日

最初の投稿 (見積もり)

2017年1月2日

学習記録の更新

投稿された最後の更新 (実際)

2017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

2017年11月17日

最終確認日

2017年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CR108250
  • 2016-003894-16 (EudraCT番号)
  • 61393215EDI1002 (その他の識別子:Janssen Research & Development, LLC)

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米国FDA規制医薬品の研究

いいえ

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JNJ-61393215の臨床試験

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