- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02398591
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants
6 luglio 2017 aggiornato da: Janssen Sciences Ireland UC
A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Subjects
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ 53718678 when administered as single dose in fasting conditions in healthy Japanese adult participants in 3 cohorts.
Panoramica dello studio
Descrizione dettagliata
This is a Phase 1, single center, double-blind (study in which neither the researchers nor the participants know what treatment the participants are receiving), placebo-controlled (study in which the experimental treatment or procedure is compared to placebo treatment), randomized (study medication assigned to participants by chance) study in healthy Japanese adult participants residing outside of Japan.
The study will consist of a Screening phase, an In-clinic treatment phase, and a follow-up phase.
The study duration for each participant will be approximately 6 weeks from Screening (Day -28 to Day -2) to follow up visit (Day 10 to 14).
Participants will be randomly assign to receive JNJ 53718678 or placebo, at planned dose of 250, 500 and 1000 milligram (mg).
Planned doses will be stepwise escalated, if the safety and tolerability of the preceding dose(s) are found to be acceptable, and the maximum tolerated dose (MTD) is not reached.
De-escalation may be performed in order to study an intermediate dose.
The safety, tolerability and pharmacokinetic (PK) profile of JNJ-53718678 will primarily be evaluated.
Participants' safety will be monitored throughout the study.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
24
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
-
-
-
Harrow, Regno Unito
-
-
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 20 anni a 55 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and body weight measurement and skin examination), medical history, vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse rate, orthostatic hypotension, and respiratory rate), and the results of blood biochemistry, blood coagulation and hematology tests, a urinalysis, and a hematest performed at Screening, on Day -1, or Day 1 pre-dose, whichever is applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Female participants must be of non-childbearing potential: postmenopausal for at least 2 years (amenorrheal for at least 2 years and a serum follicle stimulating hormone [FSH] level greater than [>] 40 international unit per liter [IU/L] or milli IU per milliliter [mIU/mL]), or surgically sterile (have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant
- Participant must be a non-smoker for at least one month prior to Screening
- Participant must have a body mass index (BMI) (weight [kilogram{kg}]/height^2 [meter^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg
Exclusion Criteria:
- Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at Screening, on Day -1 (physical examination only), and pre-dose on Day 1, as deemed appropriate by the Investigator
- Participants with lack of good/reasonable venous access
- Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome
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: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: JNJ 53718678 250 milligram (mg)
Participants will receive either single oral dose of 250 mg of JNJ 53718678 or matching placebo on Day 1.
|
JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
|
Sperimentale: JNJ 53718678 500 mg
Participants will receive either single oral dose of 500 mg of JNJ 53718678 or matching placebo on Day 1.
|
JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
|
Sperimentale: JNJ 53718678 1000 mg
Participants will receive either single oral dose of 1000 mg of JNJ 53718678 or matching placebo on Day 1.
|
JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Lasso di tempo: Up to 72 hours post dose
|
The Cmax is the maximum observed plasma concentration.
|
Up to 72 hours post dose
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Lasso di tempo: Up to 72 hours post dose
|
The Tmax is defined as actual sampling time to reach maximum observed JNJ 53718678 concentration.
|
Up to 72 hours post dose
|
Time to Last Quantifiable Plasma Concentration (Tlast)
Lasso di tempo: Up to 72 hours post dose
|
The Tlast is the time to last observed quantifiable plasma concentration.
|
Up to 72 hours post dose
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Lasso di tempo: Up to 72 hours post dose
|
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
|
Up to 72 hours post dose
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Lasso di tempo: Up to 72 hours post dose
|
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
|
Up to 72 hours post dose
|
Apparent Initial Elimination Rate Constant (lambda [alpha])
Lasso di tempo: Up to 72 hours post dose
|
Apparent initial elimination rate constant, determined by linear regression of the data points within the first elimination phase of the ln-linear plasma concentration-time curve.
|
Up to 72 hours post dose
|
Elimination Rate Constant (Lambda[z])
Lasso di tempo: Up to 72 hours post dose
|
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
|
Up to 72 hours post dose
|
Apparent Initial Elimination Half-life (t1/2[alpha])
Lasso di tempo: Up to 72 hours post dose
|
Apparent initial elimination half-life is calculated as 0.693/lambda(alpha).
|
Up to 72 hours post dose
|
Elimination Half-Life (t1/2)
Lasso di tempo: Up to 72 hours post dose
|
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration.
It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
|
Up to 72 hours post dose
|
Total Apparent Clearance (CL/F)
Lasso di tempo: Up to 72 hours post dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
Up to 72 hours post dose
|
Apparent Volume of Distribution (Vd/F)
Lasso di tempo: Up to 72 hours post dose
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after subcutaneous dose (Vd/F) is influenced by the fraction absorbed.
|
Up to 72 hours post dose
|
Number of Participants With Adverse Events
Lasso di tempo: From sign of informed consent up to end of study (Day 14)
|
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
From sign of informed consent up to end of study (Day 14)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 aprile 2015
Completamento primario (Effettivo)
15 luglio 2015
Completamento dello studio (Effettivo)
15 luglio 2015
Date di iscrizione allo studio
Primo inviato
20 marzo 2015
Primo inviato che soddisfa i criteri di controllo qualità
20 marzo 2015
Primo Inserito (Stima)
25 marzo 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 luglio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 luglio 2017
Ultimo verificato
1 luglio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CR107003
- 53718678RSV1004 (Altro identificatore: Janssen Sciences Ireland UC)
- 2014-005410-36 (Numero EudraCT)
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
prodotto fabbricato ed esportato dagli 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 53718678
-
Janssen Sciences Ireland UCNon più disponibile
-
Janssen Research & Development, LLCCompletato
-
Janssen Research & Development, LLCTerminatoInsufficienza epaticaStati Uniti
-
Janssen Sciences Ireland UCTerminatoInfezioni da virus respiratorio sincizialeStati Uniti, Belgio, Taiwan, Israele, Giappone, Argentina, Malaysia, Corea, Repubblica di, Olanda, Spagna, Australia, Italia, Brasile, Francia, Regno Unito, Svezia, Bulgaria
-
Janssen Research & Development, LLCTerminatoVirus respiratorio sincizialeStati Uniti, Germania, Italia, Ucraina, Spagna, Svezia, Tailandia, Argentina, Bulgaria, Giappone, Polonia, Canada, Ungheria, Sud Africa
-
Janssen Research & Development, LLCCompletatoVirus respiratori sincizialiTaiwan, Belgio, Regno Unito, Argentina, Panama
-
Janssen Research & Development, LLCTerminatoInfezioni delle vie respiratorieBelgio, Cechia, Taiwan, Giappone, Ungheria, Tailandia, Stati Uniti, Germania, Corea, Repubblica di, Tacchino, Cina, Spagna, Brasile, Bulgaria, Malaysia, Estonia, Argentina, Polonia, Israele, Italia, Lettonia, Messico, Panama, Sl... e altro ancora
-
Janssen Research & Development, LLCCompletato
-
Janssen Research & Development, LLCCompletatoInfezioni da virus respiratorio sincizialeStati Uniti, Taiwan, Giappone, Corea, Repubblica di, Francia, Messico, Brasile, Svezia, Argentina, Ucraina, Canada, Spagna, Germania, Polonia, Belgio, Federazione Russa, Sud Africa, Australia, Bulgaria
-
Janssen Research & Development, LLCCompletato