- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02398591
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants
6 juillet 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
24
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Harrow, Royaume-Uni
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 55 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
Délai: Up to 72 hours post dose
|
The Cmax is the maximum observed plasma concentration.
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Up to 72 hours post dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Délai: Up to 72 hours post dose
|
The Tmax is defined as actual sampling time to reach maximum observed JNJ 53718678 concentration.
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Up to 72 hours post dose
|
|
Time to Last Quantifiable Plasma Concentration (Tlast)
Délai: 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])
Délai: 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])
Délai: 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.
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Up to 72 hours post dose
|
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Apparent Initial Elimination Rate Constant (lambda [alpha])
Délai: 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
|
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Elimination Rate Constant (Lambda[z])
Délai: 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])
Délai: 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)
Délai: 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).
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Up to 72 hours post dose
|
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Total Apparent Clearance (CL/F)
Délai: 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)
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2015
Achèvement primaire (Réel)
15 juillet 2015
Achèvement de l'étude (Réel)
15 juillet 2015
Dates d'inscription aux études
Première soumission
20 mars 2015
Première soumission répondant aux critères de contrôle qualité
20 mars 2015
Première publication (Estimation)
25 mars 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juillet 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2017
Dernière vérification
1 juillet 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CR107003
- 53718678RSV1004 (Autre identifiant: Janssen Sciences Ireland UC)
- 2014-005410-36 (Numéro EudraCT)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .