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

17 novembre 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Interventistico

Iscrizione (Effettivo)

71

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore placebo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Lasso di tempo: up to 4 weeks
up to 4 weeks
Time To Reach The Maximum Plasma Concentration (Tmax)
Lasso di tempo: Day 1
Tmax is time to reach the maximum plasma concentration.
Day 1
Maximum Plasma Concentration (Cmax)
Lasso di tempo: Day 1
Cmax is maximum plasma concentration.
Day 1
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Day 7
Cmin is minimum observed plasma concentration during dosing interval (tau).
Day 7
Time To Reach The Maximum Plasma Concentration (Tmax)
Lasso di tempo: Day 7
Tmax is time to reach the maximum plasma concentration.
Day 7
Maximum Plasma Concentration (Cmax)
Lasso di tempo: Day 7
Cmax is maximum plasma concentration.
Day 7
Area Under the Plasma Concentration-Time Curve From Time [0 to24] (AUC[0-24])
Lasso di tempo: 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)
Lasso di tempo: Day 7
Cavg is average plasma concentration at steady state over the dosing interval.
Day 7
Fluctuation Index (FI)
Lasso di tempo: 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)
Lasso di tempo: 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])
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effect of JNJ-61393215 on Alertness/Sedation Through the Bond & Lader Visual Analogue Scale
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2017

Completamento primario (Effettivo)

1 ottobre 2017

Completamento dello studio (Effettivo)

1 ottobre 2017

Date di iscrizione allo studio

Primo inviato

30 dicembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

30 dicembre 2016

Primo Inserito (Stima)

2 gennaio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 novembre 2017

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CR108250
  • 2016-003894-16 (Numero EudraCT)
  • 61393215EDI1002 (Altro identificatore: Janssen Research & Development, LLC)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su JNJ-61393215

3
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